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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, natriuretic peptide
510(k) Number K072189
Device Name PATHFAST NTPROBNP AND D-DIMER TESTS
Applicant
MITSUBISHI KAGAKU IATRON
701 FIFTH AVENUE
FLOOR 42
SEATTLE,  WA  98104
Applicant Contact HELEN LANDICHO
Correspondent
MITSUBISHI KAGAKU IATRON
701 FIFTH AVENUE
FLOOR 42
SEATTLE,  WA  98104
Correspondent Contact HELEN LANDICHO
Regulation Number862.1117
Classification Product Code
NBC  
Date Received08/06/2007
Decision Date 02/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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