510(k) K180936 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST Telavancin (TLA) (0.002-32 ug/mL)
| Applicant | Biomerieux S.A., Marcy-L'Etoile, FR |
| Decision | Substantially Equivalent, Jul 3, 2018 |
| Received | Apr 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180936
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.