DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR

DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR is an FDA 510(k)-cleared medical device (K081789) manufactured by Siemens Healthcare Diagnostics, Inc.. 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 September 9, 2008. Regulation: 8.