SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I

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 Sysmex Xt-series, Model Xt-2000i And Xt-1800i.

Pre-market Notification Details

Device IDK021241
510k NumberK021241
Device Name:SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
ClassificationCounter, Differential Cell
Applicant SYSMEX CORPORATION OF AMERICA 6699 WILDLIFE WAY Long Grove,  IL  60047 -9596
ContactNina M Gamperling'
CorrespondentNina M 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 Received2002-04-19
Decision Date2002-06-25
Summary:summary

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