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ACON Laboratories, Inc.
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ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE is an FDA 510(k)-cleared medical device (K024350) manufactured by ACON Laboratories, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 1, 2003. Regulation: 8.