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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 K143577
Device Name XW-100 Automated Hematology Analyzer, XW QC CHECK
Applicant
Sysmex America, Inc.
577 Aptakisic Rd..
Lincolnshire,  IL  60069
Applicant Contact Peter Shearstone
Correspondent
Sysmex America, Inc.
577 Aptakisic Rd..
Lincolnshire,  IL  60069
Correspondent Contact Peter Shearstone
Regulation Number864.5220
Classification Product Code
GKZ  
Subsequent Product Code
JPK  
Date Received12/17/2014
Decision Date 10/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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