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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrin Split Products
510(k) Number K072288
Device Name PATHFAST D-DIMER
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 Number864.7320
Classification Product Code
GHH  
Date Received08/16/2007
Decision Date 05/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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