WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
Device Facts
| Record ID | K001934 |
|---|---|
| Device Name | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX |
| Applicant | Wako Chemicals USA, Inc. |
| Product Code | DFC · Immunology |
| Decision Date | Jul 24, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 866.5600 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.
