ANTI-ENA ANTIBODY TEST KIT

ANTI-ENA ANTIBODY TEST KIT is an FDA 510(k)-cleared medical device (K920386) 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 March 29, 1992. Regulation: 8.