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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 K051459
Device Name SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER
Applicant
SYSMEX AMERICA, INC.
ONE NELSON C. WHITE PARKWAY
MUNDELEIN,  IL  60060
Applicant Contact NINA GAMPERLING
Correspondent
SYSMEX AMERICA, INC.
ONE NELSON C. WHITE PARKWAY
MUNDELEIN,  IL  60060
Correspondent Contact NINA GAMPERLING
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received06/02/2005
Decision Date 09/23/2005
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
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