ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL

ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL is an FDA 510(k)-cleared medical device (K082638) 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 February 25, 2009. Regulation: 8.