De Novo DEN210056
- Device
- Procise IFX
- Contact
- kurtis r. bray
- De Novo number
- DEN210056
- Product code
- QXT
- Regulation
- 862.3115
- Classification name
- infliximab test system
- Decision
- granted (DENG)
- Decision date
- 2023-09-29
- Date received
- 2021-12-08
- Classification advisory
- Toxicology
- Review advisory
- Toxicology
- Type
- Direct
Current FDA Classification#
- Product code
- QXT
- Device name
- Infliximab Test System
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation
- 862.3115
- Implant
- N
- Life sustain/support
- N