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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 K040073
FOIA Releasable 510(k) K040073
Device Name SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
Applicant
Sysmex America, Inc.
One Nelson C. White Pkwy.
Mundelein,  IL  60060
Applicant Contact NINA GAMPERLING
Correspondent
Sysmex America, Inc.
One Nelson C. White Pkwy.
Mundelein,  IL  60060
Correspondent Contact NINA GAMPERLING
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received01/14/2004
Decision Date 03/18/2004
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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