SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION
Device Facts
| Record ID | K002528 |
|---|---|
| Device Name | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION |
| Applicant | Sienco, Inc. |
| Product Code | JBP · Hematology |
| Decision Date | Aug 31, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 864.7140 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.
