Product code LTT— Microbiology
DRIED GRAM-POSITIVE MIC/COMBO PANELS
- Classification name
- Panels, Test, Susceptibility, Antimicrobial
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Total cleared
- 50
- First cleared
- Most recent
Market context for product code LTT
FDA has cleared devices under product code LTT between 1995 and 2025, filed by 11 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- 2025
- 2020
- 2019
- 2017
- 2015
- 2013
- 2011
- 2010
- 2009
- 2006
- 2004
- 2003
- 2002
- 2001
- 2000
Top applicants under product code LTT
Recent clearances under product code LTT
- K243804 — MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
- K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
- K250084 — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
- K202343 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
- K201423 — MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
- K193536 — MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
- K193358 — MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)
- K183127 — MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)
- K172337 — MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)
- K172912 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL)
- K172255 — MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
- K162740 — MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
- K150039 — MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
- K131275 — MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
- K123933 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
- K111394 — MICROSCAN MICROSTEP
- K091949 — MICROSCAN MICROSTREP PLUS, MODEL B1027-201
- K091264 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
- K083262 — MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)
- K062773 — MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
- K062777 — MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN
- K033940 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)
- K030620 — PASCO MIC AND MIC/ID PANELS
- K024357 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
- K024353 — SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
- K021184 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
- K021078 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
- K021111 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME
- K020939 — MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE
- K020627 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN
- K020626 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
- K020160 — DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN
- K013368 — HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K013195 — HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES
- K010418 — DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
- K010159 — DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
- K011116 — PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
- K010508 — PASCO MIC AND MIC/ID PANELS
- K003619 — DRIED GRAM-POSITIVE MIC/COMBO PANELS
- K001721 — PASCO MIC AND MIC/ID PANELS
- K993102 — DRIED GRAM-POSITIVE MIC/COMBO PANELS
- K983306 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN
- K983309 — SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
- K973317 — PASCO MIC AND MIC/ID PANELS
- K972799 — DRIED GRAM-POSITIVE MIC/COMBO PANELS
- K962150 — DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
- K960366 — SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
- K935704 — DRIED GRAM-NEGATIVE MIC//COMBO PANELS
- K945235 — DRIED GRAM-POSITIVE MIC/COMBO PANELS
- K941030 — DRIED GRAM-NEGATIVE CEFPODOXIME
Data sourced from openFDA. This site is unofficial and independent of the FDA.