ELEGANCE FT4 ELISA

ELEGANCE FT4 ELISA is an FDA 510(k)-cleared medical device (K922284) 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 July 9, 1992. Regulation: 8.