
Beckman Coulter, Inc.
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BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER is an FDA 510(k)-cleared medical device (K130122) manufactured by Beckman Coulter, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 6, 2014. Regulation: 8.