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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 K021241
Device Name SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
Applicant
Sysmex Corporation of America
6699 Wildlife Way
Long Grove,  IL  60047 -9596
Applicant Contact NINA M GAMPERLING'
Correspondent
Sysmex Corporation of America
6699 Wildlife Way
Long Grove,  IL  60047 -9596
Correspondent Contact NINA M GAMPERLING'
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received04/19/2002
Decision Date 06/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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