HOLESTEROL DELTA TEST ASSAY
Device Facts
| Record ID | K771582 |
|---|---|
| Device Name | HOLESTEROL DELTA TEST ASSAY |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product Code | CHH · Clinical Chemistry |
| Decision Date | Sep 13, 1977 |
| 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.
