DIMENSION VISA HBA1C, MODEL K3105A

DIMENSION VISA HBA1C, MODEL K3105A is an FDA 510(k)-cleared medical device (K102045) manufactured by Siemens Heatlhcare Diagnostics, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 13, 2011. Regulation: 8.