Cleared Traditional

EUROIMMUN LYME ELISA(IgG/IgM)

K142038 · Euroimmun US · Microbiology
May 2015
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K142038 is an FDA 510(k) clearance for the EUROIMMUN LYME ELISA(IgG/IgM), a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on May 4, 2015, 280 days after receiving the submission on July 28, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K142038 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2014
Decision Date May 04, 2015
Days to Decision 280 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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