510(k) K183031 · JWY Manual Antimicrobial Susceptibility Test Systems
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
| Applicant | Biomerieux S.A., Marcy-L'Etoile, FR |
| Decision | Substantially Equivalent, Jan 11, 2019 |
| Received | Nov 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183031
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.