510(k) K981137 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST CEFOTAXIME
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, Jun 9, 1998 |
| Received | Mar 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2015 | BioMerieux SA Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic. Terminated |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.