510(k) K894539

SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER by Toa Medical Electronics USA, Inc. — Product Code GKL

K894539 is an FDA 510(k) premarket notification submitted by Toa Medical Electronics USA, Inc. for the device "SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER". The FDA issued a decision of Substantially Equivalent on September 26, 1989. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Toa Medical Electronics USA, Inc. has at least 10 other 510(k) clearances on record.