Cleared Traditional

ELVI NON-ESTERIFIED FATTY ACIDS

K792555 · Volu Sol Medical Industries · Chemistry
Jan 1980
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K792555 is an FDA 510(k) clearance for the ELVI NON-ESTERIFIED FATTY ACIDS, a Titrimetric, Fatty Acids (Class I — General Controls, product code JLH), submitted by Volu Sol Medical Industries (Walker, US). The FDA issued a Cleared decision on January 16, 1980, 37 days after receiving the submission on December 10, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1290.

Submission Details

510(k) Number K792555 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 1979
Decision Date January 16, 1980
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JLH — Titrimetric, Fatty Acids
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1290