510(k) K232215
K232215 is an FDA 510(k) premarket notification submitted by Hemosonics, LLC for the device "Quantra Hemostasis Analyzer". The FDA issued a decision of Substantially Equivalent on August 24, 2023. 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
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 2023
- Date Received
- July 26, 2023
- Clearance Type
- Special
- 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.