VITEK MS
FDA 510(k) clearance K181412 · decided 2018-12-21
Clearance details
- K-number
- K181412
- Device name
- VITEK MS
- Applicant
- bioMerieux, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-05-30
- Decision date
- 2018-12-21
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- QBN
- Device class
- 2
- Regulation number
- 866.3378
- 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 |
|---|---|---|
| MBT Compass HT CA Software; MBT FAST Shuttle US IVD (K251495) | Bruker Daltonics GmbH & Co. KG | 2025-08-13 |
| VITEK MS PRIME (K212461) | bioMerieux, Inc. | 2022-03-15 |
| MALDI Biotyper CA System (DEN170081) | Bruker Daltonik GmbH | 2018-04-20 |
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 |