
ACON Laboratories, Inc.
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ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP is an FDA 510(k)-cleared medical device (K033041) manufactured by ACON Laboratories, Inc.. 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 November 20, 2003. Regulation: 8.