510(k) K892421

MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST by Lipogen, Inc. — Product Code LJM

K892421 is an FDA 510(k) premarket notification submitted by Lipogen, Inc. for the device "MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST". The FDA issued a decision of Substantially Equivalent on May 9, 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.