Cleared Traditional

TOTAL LIPIDS REAGENT SET

K860112 · Technostics Intl. · Chemistry
Jan 1986
Decision
11d
Days
Class 1
Risk

About This 510(k) Submission

K860112 is an FDA 510(k) clearance for the TOTAL LIPIDS REAGENT SET, a Sulfophosphovanillin, Colorimetry, Total Lipids (Class I — General Controls, product code CFD), submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on January 24, 1986, 11 days after receiving the submission on January 13, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1470.

Submission Details

510(k) Number K860112 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1986
Decision Date January 24, 1986
Days to Decision 11 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