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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 K031512
Device Name EMIT II PLUS COCAINE METABOLITE ASSAY
Applicant
DADE BEHRING, INC.
p.o. box 6101
newark,,  DE  19714
Contact kathleen a dray-lyons
Regulation Number862.3250
Classification Product Code
DIO  
Date Received05/14/2003
Decision Date 07/23/2003
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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