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Bio-Rad
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LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 is an FDA 510(k)-cleared medical device (K032017) 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 August 7, 2003. Regulation: 8.