CHOLESTEROL TEST ITEM NUMBER: SR1011
Device Facts
| Record ID | K885023 |
|---|---|
| Device Name | CHOLESTEROL TEST ITEM NUMBER: SR1011 |
| Applicant | Em Diagnostic Systems, Inc. |
| Product Code | CHH · Clinical Chemistry |
| Decision Date | Feb 17, 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.
