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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diluent, Blood Cell
510(k) Number K882267
Device Name SYSMEX QUICKLYSER-II (QLS-200A)
Applicant
Toa Medical Electronics USA, Inc.
4410 Cerritos Ave.
Los Alamitos,  CA  90720
Applicant Contact ROLANDE DECHAINE
Correspondent
Toa Medical Electronics USA, Inc.
4410 Cerritos Ave.
Los Alamitos,  CA  90720
Correspondent Contact ROLANDE DECHAINE
Regulation Number864.8200
Classification Product Code
GIF  
Date Received05/31/1988
Decision Date 07/12/1988
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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