MALDI Biotyper CA System
FDA 510(k) clearance DEN170081 · decided 2018-04-20
Clearance details
- K-number
- DEN170081
- Device name
- MALDI Biotyper CA System
- Applicant
- Bruker Daltonik GmbH
- Decision
- Unknown
- Date received
- 2017-09-29
- Decision date
- 2018-04-20
- Days to decision
- 203 days
- Clearance type
- Direct
- 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 |
|---|---|---|
| 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 |
| VITEK MS (K181412) | bioMerieux, Inc. | 2018-12-21 |
Recalls involving this device
No recalls on record reference this clearance.