510(k) K061376

EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 by Theratest Laboratories, Inc. — Product Code MOB

K061376 is an FDA 510(k) premarket notification submitted by Theratest Laboratories, Inc. for the device "EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3". The FDA issued a decision of Substantially Equivalent on July 20, 2006. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Theratest Laboratories, Inc. has at least 10 other 510(k) clearances on record.