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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K030545
Device Name CRP-LATEX (II)X2 SEIKEN ASSAY KIT
Applicant
Denka Seiken Co., Ltd.
Kagamida Facility
1-2-2 Minamihoncho,
Gosen City, Niigata,  JP 959-1695
Applicant Contact TOSHIMI MATSUNAGA
Correspondent
Denka Seiken Co., Ltd.
Kagamida Facility
1-2-2 Minamihoncho,
Gosen City, Niigata,  JP 959-1695
Correspondent Contact TOSHIMI MATSUNAGA
Regulation Number866.5270
Classification Product Code
DCK  
Date Received02/20/2003
Decision Date 06/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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