Cleared Traditional

Lyme B. burgdorferi (IgM) MarStripe Test

K172254 · Trinity Biotech · Microbiology
Oct 2017
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K172254 is an FDA 510(k) clearance for the Lyme B. burgdorferi (IgM) MarStripe Test, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Trinity Biotech (Buffalo, US). The FDA issued a Cleared decision on October 23, 2017, 89 days after receiving the submission on July 26, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K172254 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2017
Decision Date October 23, 2017
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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