EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE
Device Facts
| Record ID | K890990 |
|---|---|
| Device Name | EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE |
| Applicant | Hichem Diagnostics |
| Product Code | CHH · Clinical Chemistry |
| Decision Date | Apr 10, 1989 |
| 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.
