Cleared Traditional

Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack

K173691 · Quidel Corporation · Microbiology
Feb 2018
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K173691 is an FDA 510(k) clearance for the Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Quidel Corporation (San Diego,, US). The FDA issued a Cleared decision on February 28, 2018, 89 days after receiving the submission on December 1, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K173691 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2017
Decision Date February 28, 2018
Days to Decision 89 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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