Cleared Traditional

TRU LEGIONELLA

K113190 · Meridian Bioscience, Inc. · Microbiology
Feb 2012
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K113190 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 24, 2012, 116 days after receiving the submission on October 31, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number K113190 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2011
Decision Date February 24, 2012
Days to Decision 116 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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

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