510(k) K170670 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, May 31, 2017 |
| Received | Mar 6, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170670
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445 Open, Classified |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.