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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemoglobin, Automated
510(k) Number K910745
Device Name HEMOGLOBIN REAGENT
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 Number864.5620
Classification Product Code
GKR  
Date Received02/21/1991
Decision Date 07/11/1991
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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