De Novo DEN090004
- Device
- OVA1 TEST
- Contact
- gillian crutcher
- De Novo number
- DEN090004
- Product code
- ONX
- Regulation
- 866.6050
- Classification name
- ovarian adnexal mass assessment score test system
- Decision
- granted (DENG)
- Decision date
- 2009-09-11
- Date received
- 2009-07-22
- Classification advisory
- Obstetrics/Gynecology
- Review advisory
- Immunology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- ONX
- Device name
- Ovarian Adnexal Mass Assessment Score Test System
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation
- 866.6050
- Implant
- N
- Life sustain/support
- N