ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY

ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY is an FDA 510(k)-cleared medical device (K954830) manufactured by Orgentec. 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 7, 1996. Regulation: 8.