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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
Recalls CDRH Recalls
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