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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 K121794
Model 195, 196, 198X
Device Name LIQUICHEK URINE CHEMISTRY CONTROL
Original Applicant
BIO-RAD, DIAGNOSTICS GRP.
9500 jeronimo rd.
irvine,  CA  92618 2017
Original Contact suzanne parsons
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/19/2012
Decision Date 07/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
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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