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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 K121166
Device Name WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
Original Applicant
GUANGZHOU WONDFO BIOTECH CO., LTD.
504 east diamond ave
suite f
gaithersburg,  MD  20878
Original Contact joe shia
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DJG   DJR   LAF   LCM   LFG  
Date Received04/17/2012
Decision Date 05/08/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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