Cleared Traditional

Lyme B. burgdorferi (IgG) MarStripe Test

K163095 · Trinity Biotech · Microbiology
Feb 2017
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K163095 is an FDA 510(k) clearance for the Lyme B. burgdorferi (IgG) 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 February 1, 2017, 89 days after receiving the submission on November 4, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K163095 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 2016
Decision Date February 01, 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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