TRU Legionella— 510(k) K163273

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K163273 for TRU Legionella, Substantially Equivalent on 2017-02-21. 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: 2016-11-21
Decision date: 2017-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.