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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, C-Reactive Protein
510(k) Number K083412
Device Name PATHFAST HSCRP
Applicant
Mitsubishi Kagaku Iatron
701 Fifth Ave., Floor 42
Seattle,  WA  98104
Applicant Contact HELEN LANDICHO
Correspondent
Mitsubishi Kagaku Iatron
701 Fifth Ave., Floor 42
Seattle,  WA  98104
Correspondent Contact HELEN LANDICHO
Regulation Number866.5270
Classification Product Code
DCN  
Subsequent Product Code
JIT  
Date Received11/18/2008
Decision Date 03/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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