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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Test System NameNative Diagnostics, Inc. DrugSmart Dip Drug Screen Card  (Dip Card format)
Document NumberK113046
Analyte NameMethylenedioxymethamphetamine (MDMA)
Analyte SpecialtyToxicology / TDM
ComplexityMODERATE
Effective Date01/12/2012
Device Classification Name enzyme immunoassay, amphetamine
510(k) Number K113046
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 (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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