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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometric Method, Cpk Or Isoenzymes
510(k) Number K081360
Device Name PATHFAST CK-MB-II, PATHFAST MYO-II
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 Number862.1215
Classification Product Code
JHX  
Subsequent Product Codes
DDR   JIT  
Date Received05/15/2008
Decision Date 08/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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
Recalls CDRH Recalls
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