Durham, NC, US · 7 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QFR | Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties | Class II | Hematology | 7 | 2025-08-25 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-08-25 | K251404 | Quantra QStat Cartridge | QFR | Class II | Hematology |
| 2024-03-27 | K240045 | QStat Cartridge | QFR | Class II | Hematology |
| 2023-08-24 | K232215 | Quantra Hemostasis Analyzer | QFR | Class II | Hematology |
| 2023-03-24 | K230461 | Quantra Hemostasis Analyzer | QFR | Class II | Hematology |
| 2022-12-13 | K223433 | Quantra QPlus System | QFR | Class II | Hematology |
| 2022-11-29 | K213917 | QStat Cartridge | QFR | Class II | Hematology |
| 2020-08-21 | K201513 | Quantra QPlus System | QFR | Class II | Hematology |