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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Cell, Automated (Particle Counter)
510(k) Number K981950
Device Name SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500
Applicant
Sysmex Corp.
One Wildlife Way
Long Grove,  IL  60047 -9596
Applicant Contact CATHERINE M TRESTER
Correspondent
Sysmex Corp.
One Wildlife Way
Long Grove,  IL  60047 -9596
Correspondent Contact CATHERINE M TRESTER
Regulation Number864.5200
Classification Product Code
GKL  
Date Received06/03/1998
Decision Date 11/03/1998
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
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