510(k) K936023

SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER by Toa Medical Electronics USA, Inc. — Product Code GKZ

K936023 is an FDA 510(k) premarket notification submitted by Toa Medical Electronics USA, Inc. for the device "SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER". The FDA issued a decision of Substantially Equivalent on May 2, 1994. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Toa Medical Electronics USA, Inc. has at least 10 other 510(k) clearances on record.