510(k) K072149

ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 by Phadia US, Inc. — Product Code LLL

K072149 is an FDA 510(k) premarket notification submitted by Phadia US, Inc. for the device "ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01". The FDA issued a decision of Substantially Equivalent on January 15, 2008. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Phadia US, Inc. has at least 10 other 510(k) clearances on record.