510(k) K970210 ยท JWY Manual Antimicrobial Susceptibility Test Systems
AMIKACIN
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, May 1, 1997 |
| Received | Jan 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970210
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218 Open, Classified |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.