510(k) K231433 ยท NGZ Susceptibility Test Plate, Antifungal
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Aug 31, 2023 |
| Received | May 17, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231433
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.