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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name enzyme immunoassay, cocaine and cocaine metabolites
510(k) Number K112071
Device Name WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
Original Applicant
GUANGZHOU WONDFO BIOTECH CO., LTD.
504 east diamond ave.
suite f
gaithersbrug,  MD  20878
Original Contact joe shia
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Code
LAF  
Date Received07/20/2011
Decision Date 09/23/2011
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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