510(k) K822346

HISTIMUNE ENZYME-ANA TEST by Icl Scientific — Product Code LJM

K822346 is an FDA 510(k) premarket notification submitted by Icl Scientific for the device "HISTIMUNE ENZYME-ANA TEST". The FDA issued a decision of Substantially Equivalent on October 8, 1982. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Icl Scientific has at least 10 other 510(k) clearances on record.