K223635 is an FDA 510(k) clearance for the Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer. This device is classified as a Activated Whole Blood Clotting Time (Class II - Special Controls, product code JBP).
Submitted by Sienco, Inc. (Boulder, US). The FDA issued a Cleared decision on January 4, 2023, 30 days after receiving the submission on December 5, 2022.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7140.
| 510(k) Number | K223635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2022 |
| Decision Date | January 04, 2023 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JBP - Activated Whole Blood Clotting Time |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7140 |