510(k) K172150 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Sep 15, 2017 |
| Received | Jul 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172150
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046 Open, Classified |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.