SYSMEX MODEL XT-4000I

Counter, Differential Cell

SYSMEX AMERICA, INC.

The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Model Xt-4000i.

Pre-market Notification Details

Device IDK091313
510k NumberK091313
Device Name:SYSMEX MODEL XT-4000I
ClassificationCounter, Differential Cell
Applicant SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein,  IL  60060
ContactSharita Brooks
CorrespondentSharita Brooks
SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein,  IL  60060
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-04
Decision Date2010-03-30
Summary:summary

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