510(k) K092600

IMMULISA PR3 ANTIBODY ELISA by Immco Diagnostics, Inc. — Product Code MOB

K092600 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "IMMULISA PR3 ANTIBODY ELISA". The FDA issued a decision of Substantially Equivalent on October 7, 2010. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.