
Beckman Coulter, Inc.
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IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR is an FDA 510(k)-cleared medical device (K983340) 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 December 13, 1998. Regulation: 8.