510(k) K252580

iQ200 Series by Beckman Coulter, Inc. — Product Code LKM

K252580 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "iQ200 Series". The FDA issued a decision of Substantially Equivalent on September 10, 2025. The device falls under product code LKM (Counter, Urine Particle), a Class II device regulated under 21 CFR 864.5200. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.