510(k) K981139 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST CEFTRIAXONE
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, Jun 1, 1998 |
| Received | Mar 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981139
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302 Open, Classified |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.