21 CFR 862.1290 — Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1290
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JLG | Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids | 1 | 2 | |
| JLH | Titrimetric, Fatty Acids | 1 | 1 |
