510(k) K042390 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST FOR GEMIFLOXACIN
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, Nov 19, 2004 |
| Received | Sep 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042390
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.