510(k) K250274 · JWY Manual Antimicrobial Susceptibility Test Systems
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
| Applicant | Biomerieux S.A., Marcy-L'Etoile, FR |
| Decision | Substantially Equivalent, Apr 30, 2025 |
| Received | Jan 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250274
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.