TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT

TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT is an FDA 510(k)-cleared medical device (K894761) manufactured by Hybritech, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 12, 1989. Regulation: 8.