DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360

DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 is an FDA 510(k)-cleared medical device (K083579) 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 February 19, 2009. Regulation: 8.