510(k) K882370

SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER by Toa Medical Electronics USA, Inc. — Product Code GKZ

K882370 is an FDA 510(k) premarket notification submitted by Toa Medical Electronics USA, Inc. for the device "SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER". The FDA issued a decision of Substantially Equivalent on August 25, 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.