BETA HCG EXTENDED RANGE ACCESSORY KIT

BETA HCG EXTENDED RANGE ACCESSORY KIT is an FDA 510(k)-cleared medical device (K852183) manufactured by Abbott Laboratories. 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 8, 1985. Regulation: 8.