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Bio-Rad
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LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 is an FDA 510(k)-cleared medical device (K032611) manufactured by Bio-Rad. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 16, 2003. Regulation: 8.