CFD · Sulfophosphovanillin, Colorimetry, Total Lipids
Clinical Chemistry · 21 CFR 862.1470 · Class 1
Overview
| Product Code | CFD |
|---|---|
| Device Name | Sulfophosphovanillin, Colorimetry, Total Lipids |
| Regulation | 21 CFR 862.1470 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A lipid (total) test system is a device intended to measure total lipids (fats or fat-like substances) in serum and plasma. Lipid (total) measurements are used in the diagnosis and treatment of various diseases involving lipid metabolism and atherosclerosis.
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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863073 | TOTAL LIPIDS | J. D. Assoc. | Sep 9, 1986 | SESE |
| K860112 | TOTAL LIPIDS REAGENT SET | Technostics Intl. | Jan 24, 1986 | SESE |
| K820500 | TOTAL LIPID REAGENT SET | Anco Medical Reagents & Assoc. | Mar 11, 1982 | SESE |
| K813469 | LIPID PROFILE | Bio-Analytics Laboratories, Inc. | Dec 31, 1981 | SESE |
Top Applicants
- Anco Medical Reagents & Assoc. — 1 clearance
- Bio-Analytics Laboratories, Inc. — 1 clearance
- J. D. Assoc. — 1 clearance
- Technostics Intl. — 1 clearance
