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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Borrelia Serological Reagent
510(k) Number K172722
Device Name Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
Applicant
Euroimmun Us, Inc.
1 Bloomfield Ave.
Mountain Lakes,  NJ  07046
Applicant Contact Michael A. Locke
Correspondent
Euroimmun Us, Inc.
1 Bloomfield Ave.
Mountain Lakes,  NJ  07046
Correspondent Contact Michael A. Locke
Regulation Number866.3830
Classification Product Code
LSR  
Date Received09/11/2017
Decision Date 12/10/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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