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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K140916
Device Name LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
Applicant
Bio-Rad Laboratories
9500 Jeronimo Rd.
Irvine,  CA  92618 -2017
Applicant Contact SUZANNE PARSONS
Correspondent
Bio-Rad Laboratories
9500 Jeronimo Rd.
Irvine,  CA  92618 -2017
Correspondent Contact SUZANNE PARSONS
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/10/2014
Decision Date 05/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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