FDA Product Code
FDA Product Code OJQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 862.1163
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221640 | AlloMap Heart Molecular Expression Testing | Caredx, Inc. | 2023-09-13 | Traditional | PDF ↗ |
| DEN080007 | ALLOMAP MOLECULAR EXPRESSION TESTING | Xdx | 2008-08-26 | Post-NSE | — |
Product code OJQ · Class II · Cardiovascular. Data: openFDA.