TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN

TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN is an FDA 510(k)-cleared medical device (K863860) 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 November 20, 1986. Regulation: 8.