THROMBOMAX-HS WITH CALCIUM, MODEL T6540
Device Facts
| Record ID | K010158 |
|---|---|
| Device Name | THROMBOMAX-HS WITH CALCIUM, MODEL T6540 |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | GGO · Hematology |
| Decision Date | Mar 22, 2001 |
| 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.
