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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 K113501
Models 62121, 62125
Device Name AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
Original Applicant
AMEDITECH, INC.
10340 camino santa fe
san diego,  CA  92121
Original Contact brett casey
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DIS   DJC   DJG   DJR   DKZ  
JXM   JXN   LCM   LDJ   LFG  
Date Received11/25/2011
Decision Date 12/05/2011
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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