The following data is part of a De Novo classification by Biomerieux, Inc. with the FDA for Vitek Ms.
| DeNovo ID | DEN130013 |
| Device Name: | VITEK MS |
| Classification | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Applicant | BIOMERIEUX, INC. 595 Anglum Rd. Hazelwood, MO 63042 |
| Contact | Nancy Weaver |
| Product Code | PEX |
| CFR Regulation Number | 866.3361 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K124067 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Direct |
| Date Received | 2013-01-02 |
| Decision Date | 2013-08-21 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026362843 | DEN130013 | 000 |
| 03573026359096 | DEN130013 | 000 |
| 03573026359119 | DEN130013 | 000 |