Sulfophosphovanillin, Colorimetry, Total Lipids
The Sulfophosphovanillin Colorimetry Total Lipids Test is a clinical chemistry device that quantifies total lipid content in serum using the sulfophosphovanillin colorimetric reaction, in which lipids react with sulfuric acid and phosphovanillin to produce a colored product measurable spectrophotometrically, used in the assessment of hyperlipidemia and related metabolic disorders. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CFD, regulated under 21 CFR 862.1470, within the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- CFD
- Device Class
- FDA class 1
- Regulation Number
- 862.1470
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K863073 | TOTAL LIPIDS | Sep 09, 1986 | Substantially Equivalent | J. D. Assoc. |
| K860112 | TOTAL LIPIDS REAGENT SET | Jan 24, 1986 | Substantially Equivalent | Technostics Intl. |
| K820500 | TOTAL LIPID REAGENT SET | Mar 11, 1982 | Substantially Equivalent | Anco Medical Reagents & Assoc. |
| K813469 | LIPID PROFILE | Dec 31, 1981 | Substantially Equivalent | Bio-Analytics Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.