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Beckman Coulter, Inc.
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SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 is an FDA 510(k)-cleared medical device (K091742) manufactured by Beckman Coulter, Inc.. 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 August 13, 2009. Regulation: 8.