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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 K012513
Device Name LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642
Applicant
BIO-RAD
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Applicant Contact MARIA ZEBALLOS
Correspondent
BIO-RAD
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Correspondent Contact MARIA ZEBALLOS
Regulation Number862.1660
Classification Product Code
JJY  
Date Received08/06/2001
Decision Date 08/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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