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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name counter, differential cell
510(k) Number K172604
Device Name XW-100 Automated Hematology Analyzer for CLIA Waived Use
Applicant
Sysmex America, Inc.
577 Aptakisic Road
Lincolnshire,  IL  60069
Applicant Contact Michelle Abraham
Correspondent
Sysmex America, Inc.
577 Aptakisic Road
Lincolnshire,  IL  60069
Correspondent Contact Michelle Abraham
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received08/30/2017
Decision Date 11/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
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