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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Automated Blood Cell Diluting
510(k) Number K882767
Device Name SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM
Applicant
TOA MEDICAL ELECTRONICS USA, INC.
4410 CERRITOS AVE.
LOS ALAMITOS,  CA  90720
Applicant Contact PAUL N BRODEN
Correspondent
TOA MEDICAL ELECTRONICS USA, INC.
4410 CERRITOS AVE.
LOS ALAMITOS,  CA  90720
Correspondent Contact PAUL N BRODEN
Regulation Number864.5240
Classification Product Code
GKH  
Date Received07/06/1988
Decision Date 07/18/1988
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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