CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL
Device Facts
| Record ID | K902081 |
|---|---|
| Device Name | CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL |
| Applicant | Hemotec, Inc. |
| Product Code | JBP · Hematology |
| Decision Date | Jul 3, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.
