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Bayer Healthcare, LLC
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ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 is an FDA 510(k)-cleared medical device (K030102) manufactured by Bayer Healthcare, LLC. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 23, 2003. Regulation: 8.