
Beckman Coulter, Inc.
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ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 is an FDA 510(k)-cleared medical device (K021814) 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 September 26, 2002. Regulation: 8.