VITEK MS
FDA 510(k) clearance K162950 · decided 2017-07-22
Clearance details
- K-number
- K162950
- Device name
- VITEK MS
- Applicant
- bioMerieux, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-24
- Decision date
- 2017-07-22
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- PEX
- Device class
- 2
- Regulation number
- 866.3361
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Hazelwood, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MALDI Biotyper CA (MBT-CA) System, MBT smart CA System (K163536) | Bruker Daltonik GmbH | 2017-07-26 |
| MALDI Biotyper CA System (K142677) | Bruker Daltonics, Inc. | 2015-03-27 |
| MALDI BIOTYPER CA (MBT-CA) SYSTEM (K130831) | Bruker Daltonics, Inc. | 2013-11-21 |
| VITEK MS (DEN130013) | bioMerieux, Inc. | 2013-08-21 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THXID-BRAF (P120014/S012) | bioMerieux, Inc. | 2021-12-20 |
| THxID-BRAF kit (P120014/S011) | bioMerieux, Inc. | 2021-03-10 |
| THxID-BRAF assay kit (P120014/S010) | bioMerieux, Inc. | 2020-02-26 |
| THxID BRAF assay kit (P120014/S009) | bioMerieux, Inc. | 2019-08-26 |
| THxID BRAF assay kit (P120014/S008) | bioMerieux, Inc. | 2018-06-27 |
| THxID-BRAF kit (P120014/S007) | bioMerieux, Inc. | 2016-11-22 |
| VIDAS TOTAL PSA (P040008/S013) | bioMerieux, Inc. | 2016-05-31 |
| THXID-BRAF KIT (P120014/S006) | bioMerieux, Inc. | 2016-04-05 |