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Dade Behring, Inc.
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DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 is an FDA 510(k)-cleared medical device (K070853) manufactured by Dade Behring, 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 June 12, 2007. Regulation: 8.