510(k) K070910

SYSMEX MODEL UF1000I by Sysmex America, Inc. — Product Code LKM

K070910 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "SYSMEX MODEL UF1000I". The FDA issued a decision of Substantially Equivalent on May 25, 2007. 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.