510(k) K243776

Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) by Zeus Scientific — Product Code MOB

K243776 is an FDA 510(k) premarket notification submitted by Zeus Scientific for the device "Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)". The FDA issued a decision of Substantially Equivalent on May 7, 2025. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Zeus Scientific has at least 10 other 510(k) clearances on record.