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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 K020441
Device Name EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY
Applicant
Dade Behring, Inc.
Glasgow Site, P.O. Box 6101
Newark,  DE  19714
Applicant Contact KATHLEEN A DRAY-LYONS
Correspondent
Dade Behring, Inc.
Glasgow Site, P.O. Box 6101
Newark,  DE  19714
Correspondent Contact KATHLEEN A DRAY-LYONS
Regulation Number862.3250
Classification Product Code
DIO  
Date Received02/11/2002
Decision Date 03/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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