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Meretek Diagnostics, Inc.
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BREATHTEK - UBIT UBT FOR H. PYLORI is an FDA 510(k)-cleared medical device (K014225) manufactured by Meretek Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 16, 2002. Regulation: 8.