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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 K170293
Device Name Emit II Plus Cocaine Metabolite Assay
Applicant
Siemens Healthcare Diagnostics, Inc.
P.O. Box 6101
M/S 514
Newark,  DE  19714 -6101
Applicant Contact ALAN HALEY
Correspondent
Siemens Healthcare Diagnostics, Inc.
P.O. Box 6101
M/S 514
Newark,  DE  19714 -6101
Correspondent Contact ALAN HALEY
Regulation Number862.3250
Classification Product Code
DIO  
Date Received01/31/2017
Decision Date 10/25/2017
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
Predetermined Change
Control Plan Authorized		 No
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