DEN180017 is an FDA 510(k) submission for the Quantra Hemostasis Analyzer, QPlus Cartridge. This device is classified as a Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties (Class II - Special Controls, product code QFR).
Submitted by Hemosonics, LLC (Charlottesville, US). The FDA issued a Not Cleared (DENG) decision on March 12, 2019.
This device falls under the Hematology FDA review panel. Regulated under 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..
| 510(k) Number | DEN180017 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 02, 2018 |
| Decision Date | March 12, 2019 |
| Days to Decision | 344 days |
| Submission Type | Direct |
| Review Panel | Hematology (HE) |
| Summary | - |
| Product Code | QFR - Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5430 |
| 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. |