K162950 is an FDA 510(k) clearance for the VITEK MS. This device is classified as a System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates (Class II - Special Controls, product code PEX).
Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on July 22, 2017, 271 days after receiving the submission on October 24, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3361. A Mass Spectrometer System Using Matrix-assisted Laser Desorption/ Ionization - Time Of Flight (maldi-tof) For The Identification Of Microorganisms Cultured From Human Specimens..
| 510(k) Number | K162950 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2016 |
| Decision Date | July 22, 2017 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PEX — System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3361 |
| Definition | A Mass Spectrometer System Using Matrix-assisted Laser Desorption/ Ionization - Time Of Flight (maldi-tof) For The Identification Of Microorganisms Cultured From Human Specimens. |