510(k) K232416

AUTION EYE AI-4510 Urine Particle Analysis System by Arkray, Inc. — Product Code LKM

K232416 is an FDA 510(k) premarket notification submitted by Arkray, Inc. for the device "AUTION EYE AI-4510 Urine Particle Analysis System". The FDA issued a decision of Substantially Equivalent on May 3, 2024. The device falls under product code LKM (Counter, Urine Particle), a Class II device regulated under 21 CFR 864.5200. Arkray, Inc. has at least 10 other 510(k) clearances on record.