510(k) K020496

HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY by Sysmex Corporation of America — Product Code GKZ

K020496 is an FDA 510(k) premarket notification submitted by Sysmex Corporation of America for the device "HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY". The FDA issued a decision of Substantially Equivalent on April 12, 2002. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Sysmex Corporation of America has at least 2 other 510(k) clearances on record.