LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus

Reagent, Borrelia Serological Reagent

DiaSorin Inc.

The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Lyme Igg, Liaison Lyme Igg Control Set, Liaison Lyme Total Antibody Plus.

Pre-market Notification Details

Device IDK202574
510k NumberK202574
Device Name:LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
ClassificationReagent, Borrelia Serological Reagent
Applicant DiaSorin Inc. 1951 Northwestern Avenue Stillwater,  MN  55082
ContactJohn C Walter
CorrespondentCarol A Depouw
DiaSorin Inc. 1951 Northwestern Avenue Stillwater,  MN  55082
Product CodeLSR  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-04
Decision Date2021-02-18

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