ACON ONE STEP DRUG SCREEN TEST CARD

ACON ONE STEP DRUG SCREEN TEST CARD is an FDA 510(k)-cleared medical device (K020771) manufactured by ACON Laboratories, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 14, 2002. Regulation: 8.