DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 is an FDA 510(k)-cleared medical device (K090236) manufactured by Siemens Healthcare Diagnostics. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 26, 2009. Regulation: 8.