510(k) K873734

SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER by Toa Medical Electronics USA, Inc. — Product Code GKZ

K873734 is an FDA 510(k) premarket notification submitted by Toa Medical Electronics USA, Inc. for the device "SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER". The FDA issued a decision of Substantially Equivalent on November 25, 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.