ELEGANCE FERRITIN ELISA

ELEGANCE FERRITIN ELISA is an FDA 510(k)-cleared medical device (K904822) manufactured by Bioclone Australia Pty , Ltd.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 28, 1990. Regulation: 8.