510(k) K080887

SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE by Sysmex America, Inc. — Product Code LKM

K080887 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE". The FDA issued a decision of Substantially Equivalent on May 2, 2008. 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.