MALDI Biotyper CA System
FDA 510(k) clearance K142677 · decided 2015-03-27
Clearance details
- K-number
- K142677
- Device name
- MALDI Biotyper CA System
- Applicant
- Bruker Daltonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-09-19
- Decision date
- 2015-03-27
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- PEX
- Device class
- 2
- Regulation number
- 866.3361
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Billerica, MA, 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 |
| VITEK MS (K162950) | bioMerieux, Inc. | 2017-07-22 |
| 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.