510(k) K053135

SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER by Sysmex America, Inc. — Product Code LKM

K053135 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER". The FDA issued a decision of Substantially Equivalent on January 4, 2006. 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.