The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Ast Ys Flucytosine, Vitek 2 Ast Yeast Flucytosine.
| Device ID | K133952 |
| 510k Number | K133952 |
| Device Name: | VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE |
| Classification | Susceptibility Test Plate, Antifungal |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Charlene Ferrand |
| Correspondent | Jocelyn Jennings BIOMERIEUX, INC. 100 Rodolphe Street Durham, NC 27712 |
| Product Code | NGZ |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-23 |
| Decision Date | 2014-08-19 |
| Summary: | summary |