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Olympus Life Science Research Europa GmbH (Europa)
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OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 is an FDA 510(k)-cleared medical device (K080435) manufactured by Olympus Life Science Research Europa GmbH (Europa). 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 4, 2008. Regulation: 8.