De Novo DEN060007
- Device
- INTROL CF PANEL I CONTROL
- Contact
- joan gordon
- De Novo number
- DEN060007
- Product code
- NZB
- Regulation
- 866.5910
- Classification name
- quality control material, genetics, dna
- Decision
- granted (DENG)
- Decision date
- 2006-10-12
- Date received
- 2006-08-14
- Classification advisory
- Microbiology
- Review advisory
- Pathology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- NZB
- Device name
- Quality Control Material, Genetics, Dna
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.5910
- Implant
- N
- Life sustain/support
- N