RHEUMELISA ASSAY FOR SM AUTOANTIBODIES

RHEUMELISA ASSAY FOR SM AUTOANTIBODIES is an FDA 510(k)-cleared medical device (K895996) manufactured by Lipogen, 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 5, 1989. Regulation: 8.