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OTC - Over The Counter
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Document NumberK133968
Test Name Easy Healthcare Corporation, easy @ Home Multi Drug Screen Test  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number(855)822-6999
Test TypeMethylenedioxymethamphetamine (MDMA)
Effective Date12/20/2018
Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K133968
Device Name WONDFO MULTI-DRUG URINE TEST CUP, PANEL
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
504 E. Diamond Ave. Suite F
Gaithersburg,  MD  20878
Applicant Contact Joe Shia
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
504 E. Diamond Ave. Suite F
Gaithersburg,  MD  20878
Correspondent Contact Joe Shia
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received12/26/2013
Decision Date 02/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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