HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY

Counter, Differential Cell

SYSMEX CORPORATION OF AMERICA

The following data is part of a premarket notification filed by Sysmex Corporation Of America with the FDA for Hpc (hematopoietic Progenitor Cell) Parameter On The Imi Channel Of The Sysmex Se-9500 And Xe-2100, Automated Hematology.

Pre-market Notification Details

Device IDK020496
510k NumberK020496
Device Name:HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY
ClassificationCounter, Differential Cell
Applicant SYSMEX CORPORATION OF AMERICA 6699 WILDLIFE WAY Long Grove,  IL  60047 -9596
ContactNina Gamperling
CorrespondentNina Gamperling
SYSMEX CORPORATION OF AMERICA 6699 WILDLIFE WAY Long Grove,  IL  60047 -9596
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-14
Decision Date2002-04-12
Summary:summary

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