DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE

DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE is an FDA 510(k)-cleared medical device (K112142) manufactured by Siemens Healthcare Diagnostics. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 3, 2011. Regulation: 8.