ALLOMAP MOLECULAR EXPRESSION TESTING
FDA 510(k) clearance DEN080007 · decided 2008-08-26
Clearance details
- K-number
- DEN080007
- Device name
- ALLOMAP MOLECULAR EXPRESSION TESTING
- Applicant
- Xdx
- Decision
- Unknown
- Date received
- 2008-08-15
- Decision date
- 2008-08-26
- Days to decision
- 11 days
- Clearance type
- Post-NSE
- 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 Heart Molecular Expression Testing (K221640) | Caredx, Inc. | 2023-09-13 |
Recalls involving this device
No recalls on record reference this clearance.