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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, amphetamine
510(K) Number K122904
Models W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; W2010-CU; W20011-CU; W2012-CU; W2002-P;, W2003-P; W2004-P; W2005-P; W2006-P; W2007-P; W2008-P; W2009-P; W2010-P; W2011-P; W212-P
Device Name WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;
Applicant
GUANGZHOU WONDFO BIOTECH CO., LTD.
504 east diamond ave.
suite f
gaithersbrug,  MD  20878
Contact joe shia
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJG   DJR   JXM  
LAF   LCM   LDJ   LFG  
Date Received09/21/2012
Decision Date 11/15/2012
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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