510(k) K974167

WIELISA PR-3 ANCA TEST SYSTEM by Wieslab AB — Product Code MOB

K974167 is an FDA 510(k) premarket notification submitted by Wieslab AB for the device "WIELISA PR-3 ANCA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on February 17, 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.