IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL
Device Facts
| Record ID | K854179 |
|---|---|
| Device Name | IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL |
| Applicant | Clinical Data, Inc. |
| Product Code | CHH · Clinical Chemistry |
| Decision Date | Nov 25, 1985 |
| 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.
