FilmArray Pneumonia/Pneumoniaplus Control
K-Number: K190222 · 2019-05-03
Decision Date2019-05-03
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
FilmArray Pneumonia/Pneumoniaplus Control is a medical device manufactured by Maine Molecular Quality Controls, Inc.. It received FDA 510(k) clearance on 2019-05-03 under approval number K190222. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FilmArray Pneumonia/Pneumoniaplus Control?
FilmArray Pneumonia/Pneumoniaplus Control is a medical device that received FDA 510(k) clearance on 2019-05-03. It is manufactured by Maine Molecular Quality Controls, Inc.. The 510(k) number is K190222.
When was FilmArray Pneumonia/Pneumoniaplus Control approved by the FDA?
FilmArray Pneumonia/Pneumoniaplus Control received FDA 510(k) clearance on 2019-05-03, under approval number K190222.
What company makes FilmArray Pneumonia/Pneumoniaplus Control?
FilmArray Pneumonia/Pneumoniaplus Control is manufactured by Maine Molecular Quality Controls, Inc..
What is the FDA product code for FilmArray Pneumonia/Pneumoniaplus Control?
The FDA product code for FilmArray Pneumonia/Pneumoniaplus Control is PMN.
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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.