Cleared Special

TRU Legionella

K163273 · Meridian Bioscience, Inc. · Microbiology
Feb 2017
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K163273 is an FDA 510(k) clearance for the TRU Legionella, a Legionella, Spp., Elisa (Class II — Special Controls, product code MJH), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 21, 2017, 92 days after receiving the submission on November 21, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number K163273 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2016
Decision Date February 21, 2017
Days to Decision 92 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code MJH — Legionella, Spp., Elisa
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3300

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