DEN130013 is an FDA 510(k) submission 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 Not Cleared (DENG) decision on August 21, 2013.
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 | DEN130013 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | January 02, 2013 |
| Decision Date | August 21, 2013 |
| Days to Decision | 231 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | — |
| 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. |