510(k) DEN080007
- Device
- ALLOMAP MOLECULAR EXPRESSION TESTING
- Applicant
- Xdx
- 510(k) number
- DEN080007
- Product code
- OJQ
- Decision
- Unknown (DENG)
- Decision date
- 2008-08-26
- Date received
- 2008-08-15
- Regulation
- 862.1163
- Classification name
- Cardiac Allograft Gene Expression Profiling Test System
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- ROSE ROMEO
- Address
- 3260 Bayshore Blvd. Brisbane CA US 94005 94005
FDA Registration Numbers#
- 3005225997
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OJQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221640 | AlloMap Heart Molecular Expression Testing | Caredx, Inc. | 2023-09-13 |