FIBROSYSTEM
Device Facts
| Record ID | K823520 |
|---|---|
| Device Name | FIBROSYSTEM |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product Code | GKQ · Hematology |
| Decision Date | Dec 28, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7900 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A thromboplastin generation test is a device used to detect and identify coagulation factor deficiencies and coagulation inhibitors.
