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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
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 (SESE)
Regulation Medical Specialty Clinical Chemistry
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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