SPIFE CHOLESTEROL PROFILE KIT
Device Facts
| Record ID | K000603 |
|---|---|
| Device Name | SPIFE CHOLESTEROL PROFILE KIT |
| Applicant | Helena Laboratories |
| Product Code | JHO · Clinical Chemistry |
| Decision Date | Apr 17, 2000 |
| 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.
