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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 K112605
Device Name SYSMEX XN-SERIES
Applicant
Sysmex America, Inc.
577 Aptakisic Rd..
Lincolnshire,  IL  60069
Applicant Contact SHARITA BROOKS
Correspondent
Sysmex America, Inc.
577 Aptakisic Rd..
Lincolnshire,  IL  60069
Correspondent Contact Yvonne Doswell
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received09/07/2011
Decision Date 10/19/2012
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
Recalls CDRH Recalls
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