DIMENSION VISA ENZ 2 CAL

DIMENSION VISA ENZ 2 CAL is an FDA 510(k)-cleared medical device (K103612) 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 January 24, 2011. Regulation: 8.