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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Test System NameExpress Diagnostics International Inc. DrugCheck Pipette Drug Test  
Document NumberK113046
Analyte NameTricyclic antidepressants
Analyte SpecialtyToxicology / TDM
ComplexityMODERATE
Effective Date02/16/2012
Device Classification Name enzyme immunoassay, amphetamine
510(k) Number K113046
Model 62131, 62191, 62101
Device Name AMEDITECH IMMUTEST MILTI-DRUG SCREEN
Original Applicant
AMEDITECH, INC.
10340 camino santa fe
suite f
san diego,  CA  92121
Original Contact greg cerra
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JXM   JXN   LAF   LCM   LDJ   LFG  
Date Received10/13/2011
Decision Date 11/10/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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