ETEST Gepotidacin (GEP) (0.016-256 µg/mL)— 510(k) K260447
Substantially EquivalentbioMérieux SA
FDA 510(k) clearance K260447 for ETEST Gepotidacin (GEP) (0.016-256 µg/mL), Substantially Equivalent on 2026-04-21. Applicant: bioMérieux SA. Device class: 2.
Summary
ETEST Gepotidacin (GEP) (0.016-256 µg/mL) comes from bioMérieux SA and is filed under product code JWY (Manual Antimicrobial Susceptibility Test Systems).
Class II, 21 CFR 866.1640. Microbiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
bioMérieux filed from Marcy-L'Etoile, France. The record shows 69 calendar days from receipt to decision (February 11 to April 21, 2026).
Clearance details
- Applicant
- bioMérieux SA
- Product code
- Product 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
view all- 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
More clearances from bioMérieux SA
view allData sourced from openFDA. This site is unofficial and independent of the FDA.