510(k) K000596 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST GATIFLOXACIN
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, May 22, 2000 |
| Received | Feb 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000596
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.