SYSMEX XN SERIES

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 Xn Series.

Pre-market Notification Details

Device IDK141681
510k NumberK141681
Device Name:SYSMEX XN SERIES
ClassificationCounter, Differential Cell
Applicant SYSMEX AMERICA, INC. 577 Aptakisic Rd Lincolnshire,  IL  60069
ContactSharita Brooks
CorrespondentSharita Brooks
SYSMEX AMERICA, INC. 577 Aptakisic Rd Lincolnshire,  IL  60069
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-23
Decision Date2014-12-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987562432615 K141681 000

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