510(k) K871600

SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY. by Toa Medical Electronics USA, Inc. — Product Code GKZ

K871600 is an FDA 510(k) premarket notification submitted by Toa Medical Electronics USA, Inc. for the device "SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.". The FDA issued a decision of Substantially Equivalent on June 24, 1987. 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.