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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 K023828
Device Name K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
Applicant
Kamiya Biomedical Co.
910 Industry Dr.
Seattle,  WA  98188 -3412
Applicant Contact BRIAN SCHLIESMAN
Correspondent
Kamiya Biomedical Co.
910 Industry Dr.
Seattle,  WA  98188 -3412
Correspondent Contact BRIAN SCHLIESMAN
Regulation Number866.5270
Classification Product Code
DCK  
Date Received11/18/2002
Decision Date 02/04/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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