ELVI-AMINOLEVULINIC ACID

ELVI-AMINOLEVULINIC ACID is an FDA 510(k)-cleared medical device (K792407) manufactured by Volu Sol Medical Industries. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 15, 1980. Regulation: 8.