FDA Product Code
FDA Product Code QDC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Pathology
- 21 CFR Citation
- 866.6100
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K200009 | Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation | 2020-08-05 | Traditional | PDF ↗ |
| DEN170080 | Adaptive Biotechnologies clonoSEQ Assay | Adaptive Biotechnologies Corporation | 2018-09-28 | Direct | — |
Product code QDC · Class II · Pathology. Data: openFDA.