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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 K855116
Device Name SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM
Applicant
Toa Medical Electronics USA, Inc.
1515 E Del Amo Blvd.
Carson,  CA  90746
Applicant Contact PAUL N BRODEN
Correspondent
Toa Medical Electronics USA, Inc.
1515 E Del Amo Blvd.
Carson,  CA  90746
Correspondent Contact PAUL N BRODEN
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received12/23/1985
Decision Date 02/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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