510(k) K232395 · JWY Manual Antimicrobial Susceptibility Test Systems
ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
| Applicant | Biomérieux, Marcy-L'Etoile, FR |
| Decision | Substantially Equivalent, Oct 5, 2023 |
| Received | Aug 9, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232395
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.