BIOCLONE'S ELEGANCE HCG ELISA KIT

BIOCLONE'S ELEGANCE HCG ELISA KIT is an FDA 510(k)-cleared medical device (K910420) manufactured by Bioclone Australia Pty , Ltd.. 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 February 25, 1991. Regulation: 8.