Titrimetric, Fatty Acids
This device is a titrimetric clinical chemistry reagent system used to quantify fatty acids in patient specimens by titration, used in assessments of lipid metabolism, nutritional status, and conditions such as familial hyperlipidemia or malabsorption syndromes. It is classified as FDA Class 1 and requires only general controls with no premarket submission. The product code is JLH, regulated under 21 CFR 862.1290, and assigned to the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JLH
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K792555 | ELVI NON-ESTERIFIED FATTY ACIDS | Jan 16, 1980 | Substantially Equivalent | Volu Sol Medical Industries |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.