De Novo DEN160019
- Device
- CINtec Histology (50 tests), CINtec Histology (250 tests)
- Contact
- roxane bonner
- De Novo number
- DEN160019
- Product code
- PRB
- Regulation
- 864.1865
- Classification name
- cervical intraepithelial neoplasia (cin) test system
- Decision
- granted (DENG)
- Decision date
- 2017-03-04
- Date received
- 2016-05-23
- Classification advisory
- Pathology
- Review advisory
- Pathology
- Type
- Direct
Current FDA Classification#
- Product code
- PRB
- Device name
- Cervical Intraepithelial Neoplasia (Cin) Test System
- Medical specialty
- Pathology
- Device class
- 2
- Regulation
- 864.1865
- Implant
- N
- Life sustain/support
- N