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Document NumberK122904
Test Name uVera Diagnostics, Inc. CR3 Multi-Drug Urine Test Cup  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(757)461-2730
Test TypeMethylenedioxymethamphetamine (MDMA)
Effective Date10/04/2013
Device Classification Name enzyme immunoassay, amphetamine
510(k) Number K122904
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
Applicant Contact Joe Shia
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
504 EAST DIAMOND AVE.
SUITE F
GAITHERSBRUG,  MD  20878
Correspondent 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 (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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