HDL CHOLESTEROL REAGENT (PTA/MGCL2)
Device Facts
| Record ID | K890023 |
|---|---|
| Device Name | HDL CHOLESTEROL REAGENT (PTA/MGCL2) |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | LBR · Clinical Chemistry |
| Decision Date | Feb 17, 1989 |
| 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.
