THROMBIN CLOTTING TIME REAGENT
Device Facts
| Record ID | K920147 |
|---|---|
| Device Name | THROMBIN CLOTTING TIME REAGENT |
| Applicant | Helena Laboratories |
| Product Code | GJA · Hematology |
| Decision Date | May 1, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7875 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.
