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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elisa, Antibody, West Nile Virus
510(k) Number K153303
Device Name EUROIMMUN Anti-West Nile Virus ELISA (IgG)
Applicant
Euroimmun Us, Inc.
1100 The American Rd.
Morris Plains,  NJ  07950
Applicant Contact Michael Locke
Correspondent
Euroimmun Us, Inc.
1100 The American Rd.
Morris Plains,  NJ  07950
Correspondent Contact Michael Locke
Regulation Number866.3940
Classification Product Code
NOP  
Date Received11/16/2015
Decision Date 08/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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