De Novo DEN060001
- Device
- PHICAL TEST
- Contact
- patrick hanaway
- De Novo number
- DEN060001
- Product code
- NXO
- Regulation
- 866.5180
- Classification name
- calprotectin, fecal
- Decision
- granted (DENG)
- Decision date
- 2006-04-26
- Date received
- 2006-03-23
- Classification advisory
- Immunology
- Review advisory
- Immunology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- NXO
- Device name
- Calprotectin, Fecal
- Medical specialty
- Immunology
- Device class
- 2
- Regulation
- 866.5180
- Implant
- N
- Life sustain/support
- N