ADVIA 2120/2120I BODY FLUIDS

ADVIA 2120/2120I BODY FLUIDS is an FDA 510(k)-cleared medical device (K090346) 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 July 27, 2010. Regulation: 8.