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Medica Corp.
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EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT is an FDA 510(k)-cleared medical device (K123802) 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 February 28, 2013. Regulation: 8.