SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS 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 Automated Hematology Analyzer Models Xs Series.

Pre-market Notification Details

Device IDK060656
510k NumberK060656
Device Name:SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES
ClassificationCounter, Differential Cell
Applicant SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein,  IL  60060
ContactNina Gamperling
CorrespondentNina Gamperling
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 Received2006-03-13
Decision Date2006-05-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987562406807 K060656 000

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