The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek 2 Ast-ys Fluconazole.
| Device ID | K061945 |
| 510k Number | K061945 |
| Device Name: | VITEK 2 AST-YS FLUCONAZOLE |
| Classification | Susceptibility Test Plate, Antifungal |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2320 |
| Contact | Nancy Weaver |
| Correspondent | Nancy Weaver BIOMERIEUX, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2320 |
| Product Code | NGZ |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-10 |
| Decision Date | 2006-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026373047 | K061945 | 000 |