ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT

ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K890645) manufactured by Serono-Baker Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 7, 1989. Regulation: 8.