Cell-Free DNA BCT
FDA 510(k) clearance DEN200001 · decided 2020-08-07
Clearance details
- K-number
- DEN200001
- Device name
- Cell-Free DNA BCT
- Applicant
- Streck, Inc.
- Decision
- Unknown
- Date received
- 2020-01-10
- Decision date
- 2020-08-07
- Days to decision
- 210 days
- Clearance type
- Direct
- 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 (K231776) | Streck, Inc. | 2024-07-26 |
Recalls involving this device
No recalls on record reference this clearance.