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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 K894539
Device Name SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER
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 Number864.5200
Classification Product Code
GKL  
Date Received07/20/1989
Decision Date 09/26/1989
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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