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OTC - Over The Counter
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Document NumberK131811
Test Name Mercedes Scientific Inc., ClearRapids Multi-Panel Drug Test Cup  
Manufacturer NameUCP BIOSCIENCES, INC.
Consumer Information Phone Number(888)311-2716
Test TypeCocaine metabolites
Effective Date05/08/2019
Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K131811
Device Name UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST 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 Received06/19/2013
Decision Date 07/19/2013
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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