IMMUNOCAP THYRLOBULIN IMMUNOCAP

IMMUNOCAP THYRLOBULIN IMMUNOCAP is an FDA 510(k)-cleared medical device (K072661) 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 November 19, 2007. Regulation: 8.