510(k) K182062

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device by Sysmex America, Inc. — Product Code JOY

K182062 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device". The FDA issued a decision of Substantially Equivalent on October 30, 2018. The device falls under product code JOY (Device, Automated Cell-Locating), a Class II device regulated under 21 CFR 864.5260. Sysmex America, Inc. has at least 10 other 510(k) clearances on record.