K002528 is an FDA 510(k) clearance for the SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION. 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 August 31, 2000, 15 days after receiving the submission on August 16, 2000.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7140.
| 510(k) Number | K002528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2000 |
| Decision Date | August 31, 2000 |
| Days to Decision | 15 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 |