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.
| Device Type ID | 2451 |
| Device Name | Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties |
| Physical State | Automated Or Semi-automated Instrument With Ultrasound-based Technology. Cartridges With Reagents. |
| Technical Method | Ultrasound Technology To Assess Coagulation Characteristics Of Blood. |
| Target Area | Blood |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.5430 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QFR |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2451 |
| Device | Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties |
| Product Code | QFR |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 864.5430 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HEMOSONICS, LLC | ||
GRANTED | 1 | |