DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS
Device Facts
| Record ID | K905829 |
|---|---|
| Device Name | DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS |
| Applicant | Kamiya Biomedical Co. |
| Product Code | CEL · Clinical Chemistry |
| Decision Date | Jan 30, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1575 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A phospholipid test system is a device intended to measure phospholipids in serum and plasma. Measurements of phospholipids are used in the diagnosis and treatment of disorders involving lipid (fat) metabolism.
