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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 K022041
Device Name LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
Applicant
BIO-RAD LABORATORIES, INC.
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Applicant Contact MARIA ZEBALLOS
Correspondent
BIO-RAD LABORATORIES, INC.
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Correspondent Contact MARIA ZEBALLOS
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/24/2002
Decision Date 07/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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