ABBOTT TESTPACK PLUS TM HCG-COMBO

ABBOTT TESTPACK PLUS TM HCG-COMBO is an FDA 510(k)-cleared medical device (K903219) 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 September 24, 1990. Regulation: 8.