IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA

IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA is an FDA 510(k)-cleared medical device (K060157) manufactured by Immco Diagnostics, 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 May 24, 2006. Regulation: 8.