IMMUNO CONCEPTS ANCA TEST SYSTEMS

IMMUNO CONCEPTS ANCA TEST SYSTEMS is an FDA 510(k)-cleared medical device (K974478) manufactured by Immuno Concepts, 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 February 8, 1998. Regulation: 8.