BIOCLONES ELEGANCE FSH ELISA KIT

BIOCLONES ELEGANCE FSH ELISA KIT is an FDA 510(k)-cleared medical device (K904405) 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 October 25, 1990. Regulation: 8.