510(k) K250666

Alegria Flash CTD Screen by Zeus Scientific — Product Code LLL

K250666 is an FDA 510(k) premarket notification submitted by Zeus Scientific for the device "Alegria Flash CTD Screen". The FDA issued a decision of Substantially Equivalent on October 22, 2025. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Zeus Scientific has at least 10 other 510(k) clearances on record.