The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Ast-yeast Micafungin (0.06-8 Mcg/ml).
| Device ID | K151923 |
| 510k Number | K151923 |
| Device Name: | VITEK 2 AST-Yeast Micafungin (0.06-8 Mcg/mL) |
| Classification | Susceptibility Test Plate, Antifungal |
| Applicant | BIOMERIEUX, INC. 595 Anglum Road Hazelwood, MO 63042 |
| Contact | Cherece L Jones |
| Correspondent | Cherece L Jones BIOMERIEUX, INC. 595 Anglum Road Hazelwood, MO 63042 |
| Product Code | NGZ |
| Subsequent Product Code | LRG |
| Subsequent Product Code | LTT |
| Subsequent Product Code | LTW |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-13 |
| Decision Date | 2016-03-25 |
| Summary: | summary |