ENZYMATIC TRIGLYCERIDES (END POINT)
Device Facts
| Record ID | K761200 |
|---|---|
| Device Name | ENZYMATIC TRIGLYCERIDES (END POINT) |
| Applicant | Beckman Instruments, Inc. |
| Product Code | CDT · Clinical Chemistry |
| Decision Date | Dec 21, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1705 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
