WAKO NEFA C TEST
Device Facts
| Record ID | K812081 |
|---|---|
| Device Name | WAKO NEFA C TEST |
| Applicant | Wako Chemicals USA, Inc. |
| Product Code | JLG · Clinical Chemistry |
| Decision Date | Aug 12, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1290 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A fatty acids test system is a device intended to measure fatty acids in plasma and serum. Measurements of fatty acids are used in the diagnosis and treatment of various disorders of lipid metabolism.
