510(k) K954105

EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES by Scimedx Corp. — Product Code MOB

K954105 is an FDA 510(k) premarket notification submitted by Scimedx Corp. for the device "EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES". The FDA issued a decision of Substantially Equivalent on March 19, 1996. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Scimedx Corp. has at least 10 other 510(k) clearances on record.