Cleared Traditional

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

K202573 · DiaSorin, Inc. · Microbiology
Feb 2021
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K202573 is an FDA 510(k) clearance for the LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on February 18, 2021, 167 days after receiving the submission on September 4, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K202573 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2020
Decision Date February 18, 2021
Days to Decision 167 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSR — Reagent, Borrelia Serological Reagent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830

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