ADVIA 2120i, ADVIA 2120

ADVIA 2120i, ADVIA 2120 is an FDA 510(k)-cleared medical device (K162977) manufactured by Siemens Healthcare Diagnostics. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 10, 2017. Regulation: 8.