510(k) K210127

iQ200 System, iChemVELOCITY Automated Urine Chemistry System by Beckman Coulter, Inc. — Product Code LKM

K210127 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "iQ200 System, iChemVELOCITY Automated Urine Chemistry System". The FDA issued a decision of Substantially Equivalent on July 2, 2021. 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.