ETEST Gepotidacin (GEP) (0.016-256 µg/mL)— 510(k) K260447

Name: FDA 510(k) clearance K260447
Creator: U.S. Food and Drug Administration
Published: 2026-04-21

Substantially Equivalent

bioMérieux 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.

Clearance details

Applicant: bioMérieux SA
Product code: Code JWY
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2026-02-11
Decision date: 2026-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marcy-L'Etoile, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.