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ACON Laboratories, Inc.
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ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE) is an FDA 510(k)-cleared medical device (K032661) 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 October 13, 2003. Regulation: 8.