510(k) K072393

ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 by Phadia US, Inc. — Product Code LSW

K072393 is an FDA 510(k) premarket notification submitted by Phadia US, Inc. for the device "ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01". The FDA issued a decision of Substantially Equivalent on December 7, 2007. The device falls under product code LSW (Anti-Dna 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.