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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drug mixture control materials
510(k) Number K121143
Models 657, 657X, 659
Device Name LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
Original Applicant
BIO-RAD LABORATORIES
9500 jeronimo rd.
irvine,  CA  92618 2017
Original Contact suzsnne parsons
Regulation Number862.3280
Classification Product Code
DIF  
Date Received04/16/2012
Decision Date 05/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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