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De Novo DEN180017
- Device
- Quantra Hemostasis Analyzer, QPlus Cartridge
- Contact
- anne zavertnik
- De Novo number
- DEN180017
- Product code
- QFR
- Regulation
- 864.5430
- Classification name
- coagulation system for the measurement of whole blood viscoelastic properties
- Decision
- granted (DENG)
- Decision date
- 2019-03-12
- Date received
- 2018-04-02
- Classification advisory
- Hematology
- Review advisory
- Hematology
- Type
- Direct
Current FDA Classification#
- Product code
- QFR
- Device name
- Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
- Medical specialty
- Hematology
- Device class
- 2
- Regulation
- 864.5430
- Implant
- N
- Life sustain/support
- N