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OTC - Over The Counter
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Document NumberK112310
Test Name Wondfo Morphine (2000) Urine Test  (Cup Format)
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(215)369-3705
Test TypeMorphine
Effective Date09/09/2011
Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K112310
Device Name WONDFO METHADONE URINE TEST,OPIATE TEST
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 Number862.3650
Classification Product Code
DJG  
Subsequent Product Code
DJR  
Date Received08/10/2011
Decision Date 09/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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