GKQ · Test, Thromboplastin Generation
Hematology · 21 CFR 864.7900 · Class 1
Overview
| Product Code | GKQ |
|---|---|
| Device Name | Test, Thromboplastin Generation |
| Regulation | 21 CFR 864.7900 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A thromboplastin generation test is a device used to detect and identify coagulation factor deficiencies and coagulation inhibitors.
Classification Rationale
Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K823520 | FIBROSYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 28, 1982 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
