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Document NumberK132812
Test Name UCP Biosciences, Inc. UCP Multi-Drug Test Key Cups  
Manufacturer NameUCP BIOSCIENCES, INC.
Consumer Information Phone Number1(877)474-4097
Test TypeAmphetamines
Effective Date03/13/2014
Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K132812
Device Name UCP MULTI-DRUG TEST KEY CUPS
Applicant
UCP BIOSCIENCES, INC.
1445 KOLL CIRCLE, STE. 111
SAN JOSE,  CA  95112
Applicant Contact NANCY CHEN
Correspondent
UCP BIOSCIENCES, INC.
1445 KOLL CIRCLE, STE. 111
SAN JOSE,  CA  95112
Correspondent Contact NANCY CHEN
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JXM   JXN   LCM   LDJ   LFG  
Date Received09/09/2013
Decision Date 03/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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