LIPID PROFILE
Device Facts
| Record ID | K813469 |
|---|---|
| Device Name | LIPID PROFILE |
| Applicant | Bio-Analytics Laboratories, Inc. |
| Product Code | CFD · Clinical Chemistry |
| Decision Date | Dec 31, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1470 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A lipid (total) test system is a device intended to measure total lipids (fats or fat-like substances) in serum and plasma. Lipid (total) measurements are used in the diagnosis and treatment of various diseases involving lipid metabolism and atherosclerosis.
