
Phadia US, Inc.
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ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 is an FDA 510(k)-cleared medical device (K062583) manufactured by Phadia US, 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 25, 2006. Regulation: 8.