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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 K163695
Device Name Borrelia B31 ViraChip IgM Test Kit
Applicant
Viramed Biotech AG
Behringstrasse 11
Planegg,  DE 82152
Applicant Contact Martin Kintrup
Correspondent
Viralab, Inc.
105 Copperwood Way
Suite H
Oceanside,  CA  92058
Correspondent Contact Barry E Menefee
Regulation Number866.3830
Classification Product Code
LSR  
Date Received12/28/2016
Decision Date 08/22/2017
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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