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ACON Laboratories, Inc.
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ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE is an FDA 510(k)-cleared medical device (K033047) 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 February 16, 2004. Regulation: 8.