LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621

LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 is an FDA 510(k)-cleared medical device (K081683) manufactured by Siemens Healthcare Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 6, 2008. Regulation: 8.