510(k) K211539 ยท NGZ Susceptibility Test Plate, Antifungal
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
| Applicant | Thermo Fisher Scientific, Oakwood Village OH, US |
| Decision | Substantially Equivalent, Dec 15, 2021 |
| Received | May 18, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211539
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.