Skip to content
De Novo DEN160033
- Device
- ARK Voriconazole II Assay Test System
- Contact
- kenneth c. kasper
- De Novo number
- DEN160033
- Product code
- PUJ
- Regulation
- 862.3970
- Classification name
- voriconazole test system
- Decision
- granted (DENG)
- Decision date
- 2017-05-05
- Date received
- 2016-07-15
- Classification advisory
- Toxicology
- Review advisory
- Toxicology
- Type
- Direct
Current FDA Classification#
- Product code
- PUJ
- Device name
- Voriconazole Test System
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation
- 862.3970
- Implant
- N
- Life sustain/support
- N