510(k) K192050 · JWY Manual Antimicrobial Susceptibility Test Systems
ETEST Eravacycline (ERV) (0.002 32 µg/mL)
| Applicant | Biomerieux S.A., Marcy L'Etoile, FR |
| Decision | Substantially Equivalent, Sep 27, 2019 |
| Received | Jul 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192050
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553 Open, Classified |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.