510(k) K971697 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST FOR LEVOFLOXACIN
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, Jul 14, 1997 |
| Received | May 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971697
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392 Open, Classified |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.