Cleared Traditional

TOTAL LIPID REAGENT SET

K820500 · Anco Medical Reagents & Assoc. · Chemistry
Mar 1982
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K820500 is an FDA 510(k) clearance for the TOTAL LIPID REAGENT SET, a Sulfophosphovanillin, Colorimetry, Total Lipids (Class I — General Controls, product code CFD), submitted by Anco Medical Reagents & Assoc. (Mchenry, US). The FDA issued a Cleared decision on March 11, 1982, 16 days after receiving the submission on February 23, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1470.

Submission Details

510(k) Number K820500 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 1982
Decision Date March 11, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CFD — Sulfophosphovanillin, Colorimetry, Total Lipids
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1470