510(k) K261466

Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM by Zeus Scientific — Product Code MOB

K261466 is an FDA 510(k) premarket notification submitted by Zeus Scientific for the device "Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM". The FDA issued a decision of Substantially Equivalent on August 21, 2026. 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.