K213917 is an FDA 510(k) clearance for the QStat 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 Cleared decision on November 29, 2022, 349 days after receiving the submission on December 15, 2021.
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 | K213917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2021 |
| Decision Date | November 29, 2022 |
| Days to Decision | 349 days |
| Submission Type | Traditional |
| 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. |