APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC
Device Facts
| Record ID | K864393 |
|---|---|
| Device Name | APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC |
| Applicant | Intl. Diagnostic Laboratories, Ltd. |
| Product Code | MSJ · Clinical Chemistry |
| Decision Date | Jan 16, 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.
