510(k) DEN200001
- Device
- Cell-Free DNA BCT
- Applicant
- Streck, Inc.
- 510(k) number
- DEN200001
- Product code
- QMA
- Decision
- Unknown (DENG)
- Decision date
- 2020-08-07
- Date received
- 2020-01-10
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Deborah Kipp
- 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 |
|---|---|---|---|
| K231776 | Cell-Free DNA BCT | Streck, Inc. | 2024-07-26 |