TRU Legionella
K-Number: K163273 · 2017-02-21
ApplicantMeridian Bioscience, Inc.
Decision Date2017-02-21
Product CodeMJH
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
TRU Legionella is a medical device manufactured by Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2017-02-21 under approval number K163273. The device is classified under product code MJH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TRU Legionella?
TRU Legionella is a medical device that received FDA 510(k) clearance on 2017-02-21. It is manufactured by Meridian Bioscience, Inc.. The 510(k) number is K163273.
When was TRU Legionella approved by the FDA?
TRU Legionella received FDA 510(k) clearance on 2017-02-21, under approval number K163273.
What company makes TRU Legionella?
TRU Legionella is manufactured by Meridian Bioscience, Inc..
What is the FDA product code for TRU Legionella?
The FDA product code for TRU Legionella is MJH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.