FDA Product Code
FDA Product Code QMA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1676
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231776 | Cell-Free DNA BCT | Streck, Inc. | 2024-07-26 | Traditional | PDF ↗ |
| DEN200001 | Cell-Free DNA BCT | Streck, Inc. | 2020-08-07 | Direct | — |
Product code QMA · Class II · Clinical Chemistry. Data: openFDA.