510(k) K260447 · JWY Manual Antimicrobial Susceptibility Test Systems
ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
| Applicant | bioMérieux SA, Marcy-L'Etoile, FR |
| Decision | Substantially Equivalent, Apr 21, 2026 |
| Received | Feb 11, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260447
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.