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Medica Corp.
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EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 is an FDA 510(k)-cleared medical device (K091991) manufactured by Medica Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 2009. Regulation: 8.