HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT
Device Facts
| Record ID | K924637 |
|---|---|
| Device Name | HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT |
| Applicant | International Technidyne Corp. |
| Product Code | GFO · Hematology |
| Decision Date | Jan 27, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7925 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.
