Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
Hematology · 21 CFR 864.5430
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.
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4 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Hemosonics, LLCAug 25, 2025
K251404 · Quantra QStat Cartridge
- Hemosonics, LLCMar 27, 2024
K240045 · QStat Cartridge
- Hemosonics, LLCAug 24, 2023
K232215 · Quantra Hemostasis Analyzer
- Hemosonics, LLCMar 24, 2023
K230461 · Quantra Hemostasis Analyzer
- Hemosonics, LLCDec 13, 2022
K223433 · Quantra QPlus System
- Hemosonics, LLCNov 29, 2022
K213917 · QStat Cartridge
- Hemosonics, LLCAug 21, 2020
K201513 · Quantra QPlus System
- Hemosonics, LLCMar 12, 2019
DEN180017 · Quantra Hemostasis Analyzer, QPlus Cartridge