510(k) K954829

ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY by Orgentec — Product Code LJM

K954829 is an FDA 510(k) premarket notification submitted by Orgentec for the device "ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY". The FDA issued a decision of Substantially Equivalent on April 18, 1996. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Orgentec has at least 9 other 510(k) clearances on record.