
Siemens Healthcare Diagnostics, Inc.
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DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 is an FDA 510(k)-cleared medical device (K081857) manufactured by Siemens Healthcare Diagnostics, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 29, 2008. Regulation: 8.