ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT

ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT is an FDA 510(k)-cleared medical device (K853539) 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, 1985. Regulation: 8.