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OTC - Over The Counter
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Document NumberK102428
Test Name Wunder Test, Home Drug Screen (Marijuana)  
Manufacturer NameHien Helen Nguyen
Consumer Information Phone Number(408)234-1368
Test TypeCannabinoids (THC)
Effective Date06/04/2013
Device Classification Name Enzyme Immunoassay, Cannabinoids
510(k) Number K102428
Device Name WUNDER TEST
Applicant
Hien Helen Nguyen
1810 Oakland Rd.,
Suite E
San Jose,  CA  95131
Applicant Contact HIEN NGUYEN
Correspondent
Hien Helen Nguyen
1810 Oakland Rd.,
Suite E
San Jose,  CA  95131
Correspondent Contact HIEN NGUYEN
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received08/26/2010
Decision Date 04/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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