510(k) K981761

SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER by Sysmex Corp. — Product Code GKL

K981761 is an FDA 510(k) premarket notification submitted by Sysmex Corp. for the device "SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER". The FDA issued a decision of Substantially Equivalent on August 14, 1998. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Sysmex Corp. has at least 10 other 510(k) clearances on record.