ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT
Device Facts
| Record ID | K935748 |
|---|---|
| Device Name | ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT |
| Applicant | Ortho Diagnostic Systems, Inc. |
| Product Code | GJS · Hematology |
| Decision Date | Apr 26, 1995 |
| 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).
