DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)

DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) is an FDA 510(k)-cleared medical device (K083339) manufactured by Siemens Healthcare Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 8, 2009. Regulation: 8.