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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 K920544
Device Name SYSMEX HEMATOLOGY SYSTEM ACCESSORIES
Applicant
Toa Medical Electronics USA, Inc.
4410 Cerritos Ave.
Los Alamitos,  CA  90720
Applicant Contact ROBERT W PEARSON
Correspondent
Toa Medical Electronics USA, Inc.
4410 Cerritos Ave.
Los Alamitos,  CA  90720
Correspondent Contact ROBERT W PEARSON
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/06/1992
Decision Date 04/29/1992
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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