THROMBOLYTIC ACTIVITY TEST
Device Facts
| Record ID | K834301 |
|---|---|
| Device Name | THROMBOLYTIC ACTIVITY TEST |
| Applicant | Bio/Data Corp. |
| Product Code | GJA · Hematology |
| Decision Date | Feb 4, 1984 |
| 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.
