Cleared Traditional

ELVI-AMINOLEVULINIC ACID

K792407 · Volu Sol Medical Industries · Toxicology
Jan 1980
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K792407 is an FDA 510(k) clearance for the ELVI-AMINOLEVULINIC ACID, a Lead, Delta Amino Levulinic Acid (Class II — Special Controls, product code DIJ), submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on January 16, 1980, 51 days after receiving the submission on November 26, 1979. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3550.

Submission Details

510(k) Number K792407 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1979
Decision Date January 16, 1980
Days to Decision 51 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DIJ — Lead, Delta Amino Levulinic Acid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3550