Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml— 510(k) K193538
Substantially EquivalentThermo Fisher Scientific
FDA 510(k) clearance K193538 for Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml, Substantially Equivalent on 2020-03-12. Applicant: Thermo Fisher Scientific. Device class: 2.
Clearance details
- Applicant
- Thermo Fisher Scientific
- Product code
- Code JWY
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakwood Village, OH, US
Recent devices under product code JWY
view all- 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
More clearances from Thermo Fisher Scientific
view all- K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
- 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.
- K242659 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL
- K242658 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL
Recalls naming K193538
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193538.
Data sourced from openFDA. This site is unofficial and independent of the FDA.