RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11

RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 is an FDA 510(k)-cleared medical device (K992041) 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 July 22, 1999. Regulation: 8.