De Novo DEN200067
- Device
- INNOVANCE VWF Ac
- Contact
- petra dissmann
- De Novo number
- DEN200067
- Product code
- QTY
- Regulation
- 864.7293
- Classification name
- von willebrand factor assay
- Decision
- granted (DENG)
- Decision date
- 2022-09-29
- Date received
- 2020-10-28
- Classification advisory
- Hematology
- Review advisory
- Hematology
- Type
- Direct
Current FDA Classification#
- Product code
- QTY
- Device name
- Von Willebrand Factor Assay
- Medical specialty
- Hematology
- Device class
- 2
- Regulation
- 864.7293
- Implant
- N
- Life sustain/support
- N