510(k) K950328 ยท JWY Manual Antimicrobial Susceptibility Test Systems
AMOXICILLIN/CLAVULANIC ACID 2/1
| Applicant | Ab Biodisk North America, Inc., S-17136 Solna, Sweden, SE |
| Decision | Substantially Equivalent, Apr 14, 1995 |
| Received | Jan 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950328
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240 Open, Classified |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.