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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 K040822
Device Name LIQUICHEK TORCH PLUS IGM CONTROL
Applicant
BIO-RAD LABORATORIES, INC.
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Applicant Contact MARIA KEBALLOS
Correspondent
BIO-RAD LABORATORIES, INC.
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Correspondent Contact MARIA KEBALLOS
Regulation Number862.1660
Classification Product Code
JJY  
Date Received03/30/2004
Decision Date 05/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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