APO B., IMMUNOTURBIDIMETRIC ASSAY
Device Facts
| Record ID | K864228 |
|---|---|
| Device Name | APO B., IMMUNOTURBIDIMETRIC ASSAY |
| Applicant | Intl. Diagnostic Laboratories, Ltd. |
| Product Code | MSJ · Clinical Chemistry |
| Decision Date | Mar 12, 1987 |
| 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.
