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Siemens Healthcare Diagnostics, Inc.
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LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L is an FDA 510(k)-cleared medical device (K121084) manufactured by Siemens Healthcare Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 8, 2012. Regulation: 8.