K231433 is an FDA 510(k) clearance for the The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL. This device is classified as a Susceptibility Test Plate, Antifungal (Class II - Special Controls, product code NGZ).
Submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on August 31, 2023, 106 days after receiving the submission on May 17, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640. The Device Is An In Vitro Diagnostic Device Intended For Use In Determining Quantitative Susceptibility Of Candida Species To Various Antifungal Agents Diluted In Varying Concentration In A Microtiter Plate Format..
| 510(k) Number | K231433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2023 |
| Decision Date | August 31, 2023 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | NGZ — Susceptibility Test Plate, Antifungal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |
| Definition | The Device Is An In Vitro Diagnostic Device Intended For Use In Determining Quantitative Susceptibility Of Candida Species To Various Antifungal Agents Diluted In Varying Concentration In A Microtiter Plate Format. |