ELVI TOTAL BILIRUBIN & FRACTIONS

ELVI TOTAL BILIRUBIN & FRACTIONS is an FDA 510(k)-cleared medical device (K792415) manufactured by Volu Sol Medical Industries. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 1979. Regulation: 8.