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Beckman Coulter, Inc.
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CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 is an FDA 510(k)-cleared medical device (K030012) 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 January 16, 2003. Regulation: 8.