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FDA 510(k)

FilmArray Pneumonia/Pneumoniaplus Control

K-Number: K190222 · 2019-05-03

ApplicantMaine Molecular Quality Controls, Inc.
Decision Date2019-05-03
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FilmArray Pneumonia/Pneumoniaplus Control is the device name listed in this FDA 510(k) record. The listed applicant is Maine Molecular Quality Controls, Inc.. It received FDA 510(k) clearance on 2019-05-03 under 510(k) 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. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K190222.

When did FilmArray Pneumonia/Pneumoniaplus Control receive FDA 510(k) clearance?

FilmArray Pneumonia/Pneumoniaplus Control received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190222.

Who is the listed applicant for FilmArray Pneumonia/Pneumoniaplus Control?

The FDA 510(k) record lists Maine Molecular Quality Controls, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FilmArray Pneumonia/Pneumoniaplus Control?

The FDA product code for FilmArray Pneumonia/Pneumoniaplus Control is PMN.

Other records listing Maine Molecular Quality Controls, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260577FilmArray TF Control Panel M527K251526FilmArray GI Control Panel M238K241289SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlK233611SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)K230868SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative ControlK221253SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control

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Related Devices (Code: PMN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLCK260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc.K260041MDx-Chex for BCPStreck, LLCK254166MDx-Chex for BCNStreckK254167MDx-Chex for BCYStreck, LLCK251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc.

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.

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