GJB · Thrombin
Hematology · 21 CFR 864.7875 · Class 2
Overview
| Product Code | GJB |
|---|---|
| Device Name | Thrombin |
| Regulation | 21 CFR 864.7875 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K820084 | CLOTTING TIME REAGENT | American Dade | Feb 22, 1982 | SESE |
Top Applicants
- American Dade — 1 clearance
