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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 K120504
Device Name LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
Original Applicant
BIO-RAD LABORATORIES, INC.
9500 jeronimo rd.
irvine,  CA  92618 -2017
Original Contact elizabeth platt
Regulation Number862.3280
Classification Product Code
DIF  
Date Received02/21/2012
Decision Date 03/27/2012
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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