TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY

TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY is an FDA 510(k)-cleared medical device (K870520) 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 March 9, 1987. Regulation: 8.