QFR
- Product code
- QFR
- Device name
- Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.5430
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 8 (all years; only the last 3 years are listed here)
FDA classification definition
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.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251404 | 2025-08-25 | Hemosonics, LLC | Quantra QStat Cartridge | FDA |
| K240045 | 2024-03-27 | Hemosonics, LLC | QStat Cartridge |
Official FDA classification page: QFR
Classification and pathway per current FDA publications. Data from openFDA (CC0).