510(k) K193538 · 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 µg/ml
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Mar 12, 2020 |
| Received | Dec 20, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193538
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2022 | Remel Inc Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format Terminated |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.