ORGENTEC ANTI-TPO ELISA

ORGENTEC ANTI-TPO ELISA is an FDA 510(k)-cleared medical device (K952129) 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 June 19, 1995. Regulation: 8.