MBT Compass HT CA Software; MBT FAST Shuttle US IVD
FDA 510(k) clearance K251495 · decided 2025-08-13
Clearance details
- K-number
- K251495
- Device name
- MBT Compass HT CA Software; MBT FAST Shuttle US IVD
- Applicant
- Bruker Daltonics GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2025-05-15
- Decision date
- 2025-08-13
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- QBN
- Device class
- 2
- Regulation number
- 866.3378
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Bremen, DE
- 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 |
|---|---|---|
| VITEK MS PRIME (K212461) | bioMerieux, Inc. | 2022-03-15 |
| VITEK MS (K181412) | bioMerieux, Inc. | 2018-12-21 |
| MALDI Biotyper CA System (DEN170081) | Bruker Daltonik GmbH | 2018-04-20 |
Recalls involving this device
No recalls on record reference this clearance.