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FDA 510(k)

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

K-Number: K193051 · 2020-01-29

ApplicantDiaSorin, Inc.
Decision Date2020-01-29
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set is a medical device manufactured by DiaSorin, Inc.. It received FDA 510(k) clearance on 2020-01-29 under approval number K193051. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set?

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set is a medical device that received FDA 510(k) clearance on 2020-01-29. It is manufactured by DiaSorin, Inc.. The 510(k) number is K193051.

When was LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set approved by the FDA?

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set received FDA 510(k) clearance on 2020-01-29, under approval number K193051.

What company makes LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set?

LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set is manufactured by DiaSorin, Inc..

What is the FDA product code for LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set?

The FDA product code for LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set is LSR.

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Related PubMed Literature

PMID: 42105288 Evaluating regulatory oversight through major Expert review of medical devices (2026)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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