The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek Ms.
| Device ID | K181412 |
| 510k Number | K181412 |
| Device Name: | VITEK MS |
| Classification | Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Applicant | bioMerieux, Inc. 595 Anglum Rd. Hazelwood, MO 63042 |
| Contact | Jennifer Jines |
| Correspondent | Jennifer Jines bioMerieux, Inc. 595 Anglum Rd. Hazelwood, MO 63042 |
| Product Code | QBN |
| CFR Regulation Number | 866.3378 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-30 |
| Decision Date | 2018-12-21 |
| Summary: | summary |