510(k) K171883

Sysmex UF-5000 Fully Automated Urine Particle Analyzer by Sysmex America, Inc. — Product Code LKM

K171883 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "Sysmex UF-5000 Fully Automated Urine Particle Analyzer". The FDA issued a decision of Substantially Equivalent on April 23, 2018. The device falls under product code LKM (Counter, Urine Particle), a Class II device regulated under 21 CFR 864.5200. Sysmex America, Inc. has at least 10 other 510(k) clearances on record.