Product code JWY— Microbiology
PASCO MIC AND MIC/ID PANELS
- Classification name
- Manual Antimicrobial Susceptibility Test Systems
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Total cleared
- 441
- First cleared
- Most recent
Market context for product code JWY
FDA has cleared devices under product code JWY between 1981 and 2026, filed by 47 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2012
- 2011
- 2010
Top applicants under product code JWY
Recent clearances under product code JWY
1–100 of 441- K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
- K260696 — MTS Gepotidacin 0.016-256 µg/mL
- K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
- K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
- K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
- K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
- K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
- K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL
- K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.
- K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)
- K242659 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL
- K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
- K242658 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL
- K242905 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL
- K243201 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL
- K243202 — MTS Ceftobiprole 0.002-32 µg/mL
- K243169 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL
- K242653 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL
- K242657 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL
- K242021 — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml.
- K241967 — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml.
- K240445 — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.
- K232310 — Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml
- K232395 — ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
- K231988 — Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml
- K231994 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL
- K230935 — Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)
- K230479 — ComASP Cefiderocol 0.008-128
- K223844 — Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)
- K203741 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml
- K210757 — ETEST Fosfomycin (FO) (0.032-512 µg/mL)
- K211672 — MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
- K202612 — Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)
- K202423 — MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
- K200512 — ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
- K200308 — MTS Lefamulin 0.016- 256 µg/mL
- K200180 — MTS Omadacycline 0.002 - 32 ug/mL
- K193538 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml
- K193024 — Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL
- K192738 — ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
- K192355 — MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)
- K192729 — Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml
- K192345 — MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
- K192250 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL
- K192050 — ETEST Eravacycline (ERV) (0.002 32 µg/mL)
- K191908 — MTS Imipenem 0.016-256 µg/mL
- K191809 — MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
- K191953 — ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
- K190914 — MTS Doxycycline 0.016 - 256 µg/mL
- K190154 — ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
- K190109 — MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)
- K190252 — MTS Gentamicin 0.016 - 256 µg/mL
- K183527 — MTS Ciprofloxacin 0.002 - 32 µg/mL
- K183324 — Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL
- K183031 — ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
- K183140 — MTS Tetracycline 0.016 - 256 ug/mL
- K183033 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml
- K183115 — MTS Levofloxacin 0.002 - 32 µg/mL
- K182922 — MTS Omadacycline 0.002-32 µg/mL
- K182797 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL
- K182557 — MTS Eravacycline 0.002 - 32 µg/mL
- K181889 — MTS Penicillin 0.002- 32 µg/mL
- K181946 — Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL
- K181708 — MTS Plazomicin 0.016-256 µg/mL
- K180936 — ETEST Telavancin (TLA) (0.002-32 ug/mL)
- K180886 — Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
- K180339 — Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL
- K180330 — Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL
- K173817 — Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL
- K173307 — Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL
- K173209 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL
- K172542 — Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.
- K172454 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL
- K172109 — Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
- K172150 — Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)
- K172274 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL
- K171870 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 8 ug/mL
- K171906 — Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL
- K170772 — Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
- K170670 — Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
- K170892 — Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
- K163517 — Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL
- K163298 — Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL
- K162854 — Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml
- K161175 — Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL
- K153569 — Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
- K153687 — Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
- K152774 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL
- K151873 — Etest Ceftaroline (0.002 - 32ug/ml)
- K152346 — MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
- K150556 — Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)
- K150236 — Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)
- K143288 — Sensititre Susceptibility plates
- K143526 — The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
- K142338 — Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)
- K143381 — Sensititre Susceptibility Plates
- K142151 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
- K141651 — SENSITITRE SUSCEPTIBILITY PLATES
- K133847 — SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES
- K141000 — SENSITITRE SUSCEPTIBILITY PLATES
Data sourced from openFDA. This site is unofficial and independent of the FDA.