510(k) K231776
- Device
- Cell-Free DNA BCT
- Applicant
- Streck, Inc.
- 510(k) number
- K231776
- Product code
- QMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-26
- Date received
- 2023-06-16
- Regulation
- 862.1676
- Classification name
- Blood Collection Device For Cell-Free Nucleic Acid
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Wendy Royalty
- Address
- 7002 S 109th St. La Vista NE US 68128 68128
FDA Registration Numbers
- 3004597845
- 1950302
- 3017953151
- 3007478714
- 3030896267
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QMA
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN200001 | Cell-Free DNA BCT | Streck, Inc. | 2020-08-07 |