XW-100 Automated Hematology Analyzer For CLIA Waived Use

Counter, Differential Cell

Sysmex America, Inc.

The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Xw-100 Automated Hematology Analyzer For Clia Waived Use.

Pre-market Notification Details

Device IDK172604
510k NumberK172604
Device Name:XW-100 Automated Hematology Analyzer For CLIA Waived Use
ClassificationCounter, Differential Cell
Applicant Sysmex America, Inc. 577 Aptakisic Road Lincolnshire,  IL  60069
ContactMichelle Abraham
CorrespondentMichelle Abraham
Sysmex America, Inc. 577 Aptakisic Road Lincolnshire,  IL  60069
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeDual Track
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-30
Decision Date2017-11-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987562490110 K172604 000

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