HEART CHECK APOLIPOPROTEIN-B
Device Facts
| Record ID | K881433 |
|---|---|
| Device Name | HEART CHECK APOLIPOPROTEIN-B |
| Applicant | Northwest Biotech |
| Product Code | MSJ · Clinical Chemistry |
| Decision Date | Apr 21, 1988 |
| 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.
