K201513 is an FDA 510(k) clearance for the Quantra QPlus System. 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 Cleared decision on August 21, 2020, 74 days after receiving the submission on June 8, 2020.
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 | K201513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2020 |
| Decision Date | August 21, 2020 |
| Days to Decision | 74 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| 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. |