JLH · Titrimetric, Fatty Acids
Clinical Chemistry · 21 CFR 862.1290 · Class 1
Overview
| Product Code | JLH |
|---|---|
| Device Name | Titrimetric, Fatty Acids |
| Regulation | 21 CFR 862.1290 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K792555 | ELVI NON-ESTERIFIED FATTY ACIDS | Volu Sol Medical Industries | Jan 16, 1980 | SESE |
Top Applicants
- Volu Sol Medical Industries — 1 clearance
