MBT Sepsityper
FDA 510(k) clearance K193419 · decided 2020-12-27
Clearance details
- K-number
- K193419
- Device name
- MBT Sepsityper
- Applicant
- Bruker Daltonik GmbH
- Decision
- Substantially Equivalent
- Date received
- 2019-12-09
- Decision date
- 2020-12-27
- Days to decision
- 384 days
- Clearance type
- Traditional
- Product code
- QNJ
- 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 |
|---|---|---|
| Accelerate Arc System (K240854) | Accelerate Diagnostics, Inc. | 2024-09-26 |
Recalls involving this device
No recalls on record reference this clearance.