De Novo DEN190032
- Device
- HemosIL Liquid Anti-Xa
- Contact
- carol marble
- De Novo number
- DEN190032
- Product code
- QLU
- Regulation
- 864.7295
- Classification name
- anti-factor xa activity test system, apixaban
- Decision
- granted (DENG)
- Decision date
- 2020-09-17
- Date received
- 2019-06-25
- Classification advisory
- Hematology
- Review advisory
- Hematology
- Type
- Direct
Current FDA Classification#
- Product code
- QLU
- Device name
- Anti-Factor Xa Activity Test System, Apixaban
- Medical specialty
- Hematology
- Device class
- 2
- Regulation
- 864.7295
- Implant
- N
- Life sustain/support
- N