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OTC - Over The Counter
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Document NumberK123863
Test Name American Screening Corporation, Inc. Discover Drug Test Cards  
Manufacturer NameUcp Biosciences, Inc.
Consumer Information Phone Number(877)474-4097
Test TypeAmphetamines
Effective Date09/25/2013
Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K123863
Device Name UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
Applicant
Ucp Biosciences, Inc.
1445 Koll Circle, Suite 111
San Jose,  CA  95112
Applicant Contact NANCY CHEN
Correspondent
Ucp Biosciences, Inc.
1445 Koll Circle, Suite 111
San Jose,  CA  95112
Correspondent Contact NANCY CHEN
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DMB  
JXM   LCM   LDJ   LFG  
Date Received12/14/2012
Decision Date 01/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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