K231776
- 510(k) number
- K231776
- Device name
- Cell-Free DNA BCT
- Applicant
- Streck, Inc. NE · US
- Product code
- QMA — Blood Collection Device For Cell-Free Nucleic Acid
- Decision date
- 2024-07-26
- Date received
- 2023-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K231776
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.