ORTHO *APO A-1 ELISA TEST SYSTEM
Device Facts
| Record ID | K895160 |
|---|---|
| Device Name | ORTHO *APO A-1 ELISA TEST SYSTEM |
| Applicant | Medical Marketing Consultants, Inc. |
| Product Code | DEL · Immunology |
| Decision Date | Oct 6, 1989 |
| 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.
