HELENA THROMBOPLASTIN REAGENT, MODIFICATION
Device Facts
| Record ID | K905857 |
|---|---|
| Device Name | HELENA THROMBOPLASTIN REAGENT, MODIFICATION |
| Applicant | Helena Laboratories |
| Product Code | GJS · Hematology |
| Decision Date | Feb 27, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7750 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).
