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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K130628
Device Name PATHFAST CK-MB-II CALIBRATORS
Applicant
Mitsubishi Chemical Medience Corporation
2 Bethesda Metro Center,
Suite 850
Bethesda,  MD  20814
Applicant Contact Judi Smith
Correspondent
Mitsubishi Chemical Medience Corporation
2 Bethesda Metro Center,
Suite 850
Bethesda,  MD  20814
Correspondent Contact Judi Smith
Regulation Number862.1150
Classification Product Code
JIT  
Date Received03/08/2013
Decision Date 10/04/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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