TANDEM FAST VISUAL HCG ASSAY KIT -

TANDEM FAST VISUAL HCG ASSAY KIT - is an FDA 510(k)-cleared medical device (K842633) 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 August 22, 1984. Regulation: 8.