The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Ast-ys Micafungin (8 µg/ml).
| Device ID | K181368 |
| 510k Number | K181368 |
| Device Name: | VITEK 2 AST-YS Micafungin (8 µg/mL) |
| Classification | Susceptibility Test Plate, Antifungal |
| Applicant | bioMerieux, Inc. 595 Anglum Rd. Hazelwood, MO 63042 |
| Contact | Jolyn Tenllado |
| Correspondent | Jolyn Tenllado bioMerieux, Inc. 595 Anglum Rd. 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-23 |
| Decision Date | 2018-06-20 |
| Summary: | summary |