
Phadia US, Inc.
Free shipping on orders over $99 · 30-day returns
ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 is an FDA 510(k)-cleared medical device (K062787) 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 28, 2006. Regulation: 8.