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FDA 510(k)

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

K-Number: K202573 · 2021-02-18

ApplicantDiaSorin, Inc.
Decision Date2021-02-18
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus is a medical device manufactured by DiaSorin, Inc.. It received FDA 510(k) clearance on 2021-02-18 under approval number K202573. 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 IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus?

LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus is a medical device that received FDA 510(k) clearance on 2021-02-18. It is manufactured by DiaSorin, Inc.. The 510(k) number is K202573.

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

LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus received FDA 510(k) clearance on 2021-02-18, under approval number K202573.

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

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

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

The FDA product code for LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus 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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Related Devices (Code: LSR)

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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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