510(k) K221198 ยท NGZ Susceptibility Test Plate, Antifungal
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Mar 10, 2023 |
| Received | Apr 26, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221198
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.