
Dade Behring, Inc.
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DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H is an FDA 510(k)-cleared medical device (K063663) 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 March 20, 2007. Regulation: 8.