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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
Device Name LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
Applicant
Bio-Rad Laboratories
9500 jeronimo rd.
irvine,  CA  92618 -2017
Applicant Contact suzsnne parsons
Correspondent
Bio-Rad Laboratories
9500 jeronimo rd.
irvine,  CA  92618 -2017
Correspodent Contact suzsnne parsons
Regulation Number862.3280
Classification Product Code
DIF  
Date Received04/16/2012
Decision Date 05/18/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
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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