De Novo DEN220023
- Device
- Procise ADL
- Contact
- kurt bray
- De Novo number
- DEN220023
- Product code
- QYD
- Regulation
- 862.3115
- Classification name
- adalimumab assay
- Decision
- granted (DENG)
- Decision date
- 2023-09-29
- Date received
- 2022-04-04
- Classification advisory
- Toxicology
- Review advisory
- Toxicology
- Type
- Direct
Current FDA Classification#
- Product code
- QYD
- Device name
- Adalimumab Assay
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation
- 862.3115
- Implant
- N
- Life sustain/support
- N