The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Ast-yeast Fluconazole (=64 µg/ml), Vitek 2 Ast-ys Fluconazole (=64 µg/ml), Vitek 2 Ast-ys Fluconazole.
| Device ID | K213241 |
| 510k Number | K213241 |
| Device Name: | VITEK 2 AST-Yeast Fluconazole (=64 µg/mL), VITEK 2 AST-YS Fluconazole (=64 µg/mL), VITEK 2 AST-YS Fluconazole |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | BioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 |
| Contact | Esther Hernandez |
| Correspondent | Esther Hernandez BioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042 |
| Product Code | LON |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-02-25 |