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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mixture, hematology quality control
510(k) Number K042836
Device Name LIQUICHEK RETICULOCYTE CONTROL (A)
Applicant
BIO-RAD
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Applicant Contact ELIZABETH PLATT
Correspondent
BIO-RAD
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Correspondent Contact ELIZABETH PLATT
Regulation Number864.8625
Classification Product Code
JPK  
Date Received10/14/2004
Decision Date 11/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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