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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Test System NameACON COC ONE STEP COCAINE TEST STRIP  
Document NumberK010841
Analyte NameCocaine metabolites
Analyte SpecialtyToxicology / TDM
ComplexityMODERATE
Effective Date07/06/2001
Device Classification Name enzyme immunoassay, cocaine and cocaine metabolites
510(k) Number K010841
Device Name ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
Original Applicant
ACON LABORATORIES, INC.
4108 sorrento valley blvd.
san diego,  CA  92121
Original Contact robert hudak
Regulation Number862.3250
Classification Product Code
DIO  
Date Received03/21/2001
Decision Date 07/09/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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