510(k) K013283

RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 by Immuno Concepts, Inc. — Product Code MOB

K013283 is an FDA 510(k) premarket notification submitted by Immuno Concepts, Inc. for the device "RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16". The FDA issued a decision of Substantially Equivalent on November 14, 2001. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Immuno Concepts, Inc. has at least 10 other 510(k) clearances on record.