SR1 ESTRADIOL ENZYME IMMUNOASSAY

SR1 ESTRADIOL ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K911396) 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 May 27, 1991. Regulation: 8.