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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
Original Applicant
DADE BEHRING, INC.
p.o. box 6101
newark,,  DE  19714
Original Contact kathleen a dray-lyons
Regulation Number862.3250
Classification Product Code
DIO  
Date Received05/14/2003
Decision Date 07/23/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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