AlloMap Heart Molecular Expression Testing
FDA 510(k) clearance K221640 · decided 2023-09-13
Clearance details
- K-number
- K221640
- Device name
- AlloMap Heart Molecular Expression Testing
- Applicant
- Caredx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-06
- Decision date
- 2023-09-13
- Days to decision
- 464 days
- Clearance type
- Traditional
- Product code
- OJQ
- Device class
- 2
- Regulation number
- 862.1163
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Brisbane, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ALLOMAP MOLECULAR EXPRESSION TESTING (DEN080007) | Xdx | 2008-08-26 |
Recalls involving this device
No recalls on record reference this clearance.