Cleared Dual Track

Sofia 2 Lyme FIA, Sofia Lyme Control Set

K173496 · Quidel Corporation · Microbiology
Aug 2018
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K173496 is an FDA 510(k) clearance for the Sofia 2 Lyme FIA, Sofia Lyme Control Set, 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 August 30, 2018, 290 days after receiving the submission on November 13, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K173496 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2017
Decision Date August 30, 2018
Days to Decision 290 days
Submission Type Dual Track
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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