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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name control, hemoglobin
510(k) Number K070546
Device Name LYPHOCHEK DIABETES CONTROL
Applicant
Bio-Rad Laboratories
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Applicant Contact ELIZABETH PLATT
Correspondent
Bio-Rad Laboratories
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Correspondent Contact ELIZABETH PLATT
Regulation Number864.8625
Classification Product Code
GGM  
Date Received02/26/2007
Decision Date 04/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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