De Novo DEN180004
- Device
- picoAMH ELISA
- Contact
- ajay kumar
- De Novo number
- DEN180004
- Product code
- QDH
- Regulation
- 862.1093
- Classification name
- menopause test system
- Decision
- granted (DENG)
- Decision date
- 2018-10-24
- Date received
- 2018-01-22
- Classification advisory
- Clinical Chemistry
- Review advisory
- Toxicology
- Type
- Direct
Current FDA Classification#
- Product code
- QDH
- Device name
- Menopause Test System
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation
- 862.1093
- Implant
- N
- Life sustain/support
- N