510(k) K961519 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST SUBMISSION FOR AZITHROMYCIN
| Applicant | Ab Biodisk, Solna, SE |
| Decision | Substantially Equivalent, Jul 5, 1996 |
| Received | Apr 22, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961519
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.