CHOLESTECH LDX SYSTEM
Device Facts
| Record ID | K954778 |
|---|---|
| Device Name | CHOLESTECH LDX SYSTEM |
| Applicant | Cholestech Corp. |
| Product Code | LBS · Clinical Chemistry |
| Decision Date | Nov 24, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1475 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
