Cell-Free DNA BCT
FDA 510(k) clearance K231776 · decided 2024-07-26
Clearance details
- K-number
- K231776
- Device name
- Cell-Free DNA BCT
- Applicant
- Streck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-06-16
- Decision date
- 2024-07-26
- Days to decision
- 406 days
- Clearance type
- Traditional
- Product code
- QMA
- Device class
- 2
- Regulation number
- 862.1676
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- La Vista, NE, 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 |
|---|---|---|
| Cell-Free DNA BCT (DEN200001) | Streck, Inc. | 2020-08-07 |
Recalls involving this device
No recalls on record reference this clearance.