510(k) K200512 · JWY Manual Antimicrobial Susceptibility Test Systems
ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
| Applicant | Biomérieux SA, Marcy-L'Etoile, FR |
| Decision | Substantially Equivalent, May 7, 2020 |
| Received | Mar 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200512
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.