510(k) DEN180017
DEN180017 is an FDA 510(k) premarket notification submitted by Hemosonics, LLC for the device "Quantra Hemostasis Analyzer, QPlus Cartridge". The FDA issued a decision of De Novo Granted on March 12, 2019. The device falls under product code QFR (Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties), a Class II device regulated under 21 CFR 864.5430. Hemosonics, LLC has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 12, 2019
- Date Received
- April 2, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
- Device Class
- Class II
- Regulation Number
- 864.5430
- Review Panel
- HE
- Submission Type
A coagulation system for the measurement of whole blood viscoelastic properties is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in patients.