ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT
Device Facts
| Record ID | K925604 |
|---|---|
| Device Name | ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT |
| Applicant | Ortho Diagnostic Systems, Inc. |
| Product Code | GJS · Hematology |
| Decision Date | Mar 12, 1993 |
| 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).
