BIOCLONES ELEGANCE LH ELISA KIT

BIOCLONES ELEGANCE LH ELISA KIT is an FDA 510(k)-cleared medical device (K904387) manufactured by Bioclone Australia Pty , Ltd.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 5, 1990. Regulation: 8.