K232963 is an FDA 510(k) clearance for the VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL). This device is classified as a Susceptibility Test Plate, Antifungal (Class II - Special Controls, product code NGZ).
Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on June 7, 2024, 260 days after receiving the submission on September 21, 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 | K232963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2023 |
| Decision Date | June 07, 2024 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| 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. |