HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME
Device Facts
| Record ID | K860122 |
|---|---|
| Device Name | HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME |
| Applicant | Medical Device Consultants, Inc. |
| Product Code | JBP · Hematology |
| Decision Date | Apr 4, 1986 |
| 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.
