510(k) K981950

SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 by Sysmex Corp. — Product Code GKL

K981950 is an FDA 510(k) premarket notification submitted by Sysmex Corp. for the device "SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500". The FDA issued a decision of Substantially Equivalent on November 3, 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.