TRU LEGIONELLA— 510(k) K113190

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K113190 for TRU LEGIONELLA, Substantially Equivalent on 2012-02-24. Applicant: Meridian Bioscience, Inc.. Device class: 2.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code MJH
Device class: Class 2
Regulation: 21 CFR 866.3300
Advisory panel: Microbiology
Date received: 2011-10-31
Decision date: 2012-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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