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Dade Behring, Inc.
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DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH is an FDA 510(k)-cleared medical device (K063610) manufactured by Dade Behring, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 10, 2007. Regulation: 8.