ABBOTT TESTPACK (TM) HCG SERUM

ABBOTT TESTPACK (TM) HCG SERUM is an FDA 510(k)-cleared medical device (K863032) 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 14, 1986. Regulation: 8.