The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vitek Ms.
| Device ID | K162950 |
| 510k Number | K162950 |
| Device Name: | VITEK MS |
| Classification | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Applicant | bioMerieux, Inc. 595 Anglum Rd. Hazelwood, MO 63042 |
| Contact | Nathan Hardesty |
| Correspondent | Nathan Hardesty bioMerieux, Inc. 595 Anglum Rd. Hazelwood, MO 63042 |
| Product Code | PEX |
| CFR Regulation Number | 866.3361 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-24 |
| Decision Date | 2017-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03573026610418 | K162950 | 000 |
| 03573026621698 | K162950 | 000 |
| 03573026628154 | K162950 | 000 |