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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 K220016
Device Name Viramed Borrela All-In-One ViraChip Test Kit
Applicant
Viramed Biotech AG
Behringstrasse 11
Planegg,  DE 82152
Applicant Contact Martin Kintrup
Correspondent
Viralab, Inc.
1815 14th St. NW Suite D
Rochester,  MN  55901
Correspondent Contact Leonard Rollins
Regulation Number866.3830
Classification Product Code
LSR  
Date Received01/05/2022
Decision Date 08/19/2022
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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