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De Novo DEN080007
- Device
- ALLOMAP MOLECULAR EXPRESSION TESTING
- Contact
- rose romeo
- De Novo number
- DEN080007
- Product code
- OJQ
- Regulation
- 862.1163
- Classification name
- cardiac allograft gene expression profiling test system
- Decision
- granted (DENG)
- Decision date
- 2008-08-26
- Date received
- 2008-08-15
- Classification advisory
- Cardiovascular
- Review advisory
- Clinical Chemistry
- Type
- Post-NSE
Current FDA Classification#
- Product code
- OJQ
- Device name
- Cardiac Allograft Gene Expression Profiling Test System
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation
- 862.1163
- Implant
- N
- Life sustain/support
- N