510(k) K981748

WIELISA ANCA SCREENING KIT TEST SYSTEM by Wieslab AB — Product Code MOB

K981748 is an FDA 510(k) premarket notification submitted by Wieslab AB for the device "WIELISA ANCA SCREENING KIT TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 22, 1998. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Wieslab AB has at least 4 other 510(k) clearances on record.