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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name enzyme immunoassay, cocaine and cocaine metabolites
510(k) Number K113751
Model DA4011
Device Name RANDOX COCAINE METABOLITE
Original Applicant
RANDOX LABORATORIES, LTD.
55 diamond rd.
crumlin, county antrim,  UK bt29 4qy
Original Contact pauline armstrong
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DLJ   LAS  
Date Received12/21/2011
Decision Date 05/08/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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