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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameUCP Biosciences, Inc. Drug Screening Test Cards  
Document NumberK091588
Parent Document NumberK091588
Analyte NameMorphine
Analyte SpecialtyToxicology / TDM
ComplexityWAIVED
Effective Date10/18/2010
Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K091588
Device Name UCP HOME DRUG SCREENING TESTS
Applicant
Ucp Biosciences, Inc.
1445 Koll Cir., Suite 111
San Jose,  CA  95112
Applicant Contact NANCY CHEN
Correspondent
Ucp Biosciences, Inc.
1445 Koll Cir., 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 Received06/02/2009
Decision Date 09/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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