Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids
This device is a clinical chemistry reagent system that converts fatty acids to ferric hydroxamates and measures the resulting color spectrophotometrically, providing quantification of serum or plasma fatty acids used in the evaluation of lipid metabolism disorders and nutritional assessment. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls without a premarket notification. The product code is JLG, regulated under 21 CFR 862.1290, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JLG
- Device Class
- FDA class 1
- Regulation Number
- 862.1290
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.