510(k) K203741 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Dec 20, 2021 |
| Received | Dec 22, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203741
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.