ETEST Delafloxacin (DFX) (0.002-32 µg/mL)— 510(k) K192738
Substantially EquivalentBiomerieux S.A.
FDA 510(k) clearance K192738 for ETEST Delafloxacin (DFX) (0.002-32 µg/mL), Substantially Equivalent on 2019-11-26. Applicant: Biomerieux S.A.. Device class: 2.
Clearance details
- Applicant
- Biomerieux S.A.
- 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
- Marcy-L'Etoile, FR
Recent devices under product code JWY
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- 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 Biomerieux S.A.
view all- K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
- K210757 — ETEST Fosfomycin (FO) (0.032-512 µg/mL)
- K192050 — ETEST Eravacycline (ERV) (0.002 32 µg/mL)
- K191953 — ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
- K190154 — ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
Data sourced from openFDA. This site is unofficial and independent of the FDA.