TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT

TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT is an FDA 510(k)-cleared medical device (K821944) manufactured by Hybritech, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 1982. Regulation: 8.