510(k) K895994

RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES by Lipogen, Inc. — Product Code LJM

K895994 is an FDA 510(k) premarket notification submitted by Lipogen, Inc. for the device "RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES". The FDA issued a decision of Substantially Equivalent on October 24, 1989. The device falls under product code LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls), a Class II device regulated under 21 CFR 866.5100. Lipogen, Inc. has at least 10 other 510(k) clearances on record.