510(k) K250856 · JWY Manual Antimicrobial Susceptibility Test Systems
ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)
| Applicant | Biomérieux, Marcy-L'Etoile, FR |
| Decision | Substantially Equivalent, Jun 12, 2025 |
| Received | Mar 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250856
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.