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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 K130761
Device Name LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK
Applicant
Bio-Rad Laboratories
9500 Jeronimo Rd.
Irvine,  CA  92618
Applicant Contact SUZANNE PARSONS
Correspondent
Bio-Rad Laboratories
9500 Jeronimo Rd.
Irvine,  CA  92618
Correspondent Contact SUZANNE PARSONS
Regulation Number862.1660
Classification Product Code
JJY  
Date Received03/20/2013
Decision Date 04/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
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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