ORGENTEC ANTI-SM ELISA

ORGENTEC ANTI-SM ELISA is an FDA 510(k)-cleared medical device (K962062) manufactured by American Laboratory Products Co., Ltd.. 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 17, 1996. Regulation: 8.