510(k) K944168

VARELISA LA (SS-B) ANTIBODIES by Elias U.S.A., Inc. — Product Code LJM

K944168 is an FDA 510(k) premarket notification submitted by Elias U.S.A., Inc. for the device "VARELISA LA (SS-B) ANTIBODIES". The FDA issued a decision of Substantially Equivalent on December 22, 1994. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Elias U.S.A., Inc. has at least 10 other 510(k) clearances on record.