APOLIPOPROTEIN A-I (APO A-I)
Device Facts
| Record ID | K901675 |
|---|---|
| Device Name | APOLIPOPROTEIN A-I (APO A-I) |
| Applicant | Sigma Chemical Co. |
| Product Code | DEL · Immunology |
| Decision Date | Apr 26, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5590 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniques lipoprotein X (a high-density lipoprotein) in serum and other body fluids. Measurement of lipoprotein X aids in the diagnosis of obstructive liver disease.
