The following data is part of a premarket notification filed by Biomerieux Inc with the FDA for Vitek 2 Ast-ys Caspofungin =8 Ug/ml.
| Device ID | K151817 |
| 510k Number | K151817 |
| Device Name: | VITEK 2 AST-YS Caspofungin =8 Ug/mL |
| Classification | Susceptibility Test Plate, Antifungal |
| Applicant | BIOMERIEUX INC 595 ANGLUM ROAD Hazelwood, MO 63042 |
| Contact | Karen Russell |
| Correspondent | Karen Russell BIOMERIEUX INC 595 ANGLUM ROAD Hazelwood, MO 63042 |
| Product Code | NGZ |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-06 |
| Decision Date | 2016-02-18 |
| Summary: | summary |