510(k) K883997

SYSMEX NE-8000 by Toa Medical Electronics USA, Inc. — Product Code GKZ

K883997 is an FDA 510(k) premarket notification submitted by Toa Medical Electronics USA, Inc. for the device "SYSMEX NE-8000". The FDA issued a decision of Substantially Equivalent on December 5, 1988. 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.