510(k) K962055

ORGENTEC ANTI-SCL 70 ELISA by American Laboratory Products Co., Ltd. — Product Code LJM

K962055 is an FDA 510(k) premarket notification submitted by American Laboratory Products Co., Ltd. for the device "ORGENTEC ANTI-SCL 70 ELISA". The FDA issued a decision of Substantially Equivalent on November 15, 1996. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. American Laboratory Products Co., Ltd. has at least 10 other 510(k) clearances on record.