Cleared Traditional

ELVI MUCAPROTEINS

K792554 · Volu Sol Medical Industries · Chemistry
Jan 1980
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K792554 is an FDA 510(k) clearance for the ELVI MUCAPROTEINS, a Colorimetric, Mucopolysaccharides (Class I — General Controls, product code JQN), submitted by Volu Sol Medical Industries (Mchenry, 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 862.1505.

Submission Details

510(k) Number K792554 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 JQN — Colorimetric, Mucopolysaccharides
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1505