Skip to contentDe Novo DEN230024
- Device
- Technozym ADAMTS13 Activity
- Contact
- nikolaus binder
- De Novo number
- DEN230024
- Product code
- SAC
- Regulation
- 864.7297
- Classification name
- adamts13 activity test system
- Decision
- granted (DENG)
- Decision date
- 2024-02-28
- Date received
- 2023-04-06
- Classification advisory
- Hematology
- Review advisory
- Hematology
- Type
- Direct
Current FDA Classification#
- Product code
- SAC
- Device name
- Adamts13 Activity Test System
- Medical specialty
- Hematology
- Device class
- 2
- Regulation
- 864.7297
- Implant
- N
- Life sustain/support
- N