CHOLESTEROL ENZYMATIC ENDPOINT
Device Facts
| Record ID | K923504 |
|---|---|
| Device Name | CHOLESTEROL ENZYMATIC ENDPOINT |
| Applicant | Randox Laboratories, Ltd. |
| Product Code | CHH · Clinical Chemistry |
| Decision Date | Jan 10, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1175 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
