K133952 is an FDA 510(k) clearance for the VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE. 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 August 19, 2014, 239 days after receiving the submission on December 23, 2013.
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 | K133952 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2013 |
| Decision Date | August 19, 2014 |
| Days to Decision | 239 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. |