510(k) K010363 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST MEROPENEM
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, Apr 9, 2001 |
| Received | Feb 7, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010363
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401 Open, Classified |
JWY | None listed |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786 Open, Classified |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.