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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 K193051
Device Name LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
Applicant
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082
Applicant Contact John C. Walter
Correspondent
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082
Correspondent Contact Mari Meyer
Regulation Number866.3830
Classification Product Code
LSR  
Subsequent Product Code
QCH  
Date Received11/01/2019
Decision Date 01/29/2020
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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