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

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 Total Antibody Plus, Liaison Lyme Total Antibody Plus Control Set.

Pre-market Notification Details

Device IDK193051
510k NumberK193051
Device Name:LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
ClassificationReagent, Borrelia Serological Reagent
Applicant DiaSorin Inc. 1951 Northwestern Ave Stillwater,  MN  55082 -0285
ContactJohn C. Walter
CorrespondentMari Meyer
DiaSorin Inc. 1951 Northwestern Ave Stillwater,  MN  55082 -0285
Product CodeLSR  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-01
Decision Date2020-01-29
Summary:summary

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