510(k) K082759

ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY by Phadia US, Inc. — Product Code LKJ

K082759 is an FDA 510(k) premarket notification submitted by Phadia US, Inc. for the device "ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on April 10, 2009. The device falls under product code LKJ (Antinuclear Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Phadia US, Inc. has at least 10 other 510(k) clearances on record.