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FDA 510(k)

FilmArray RP EZ Control Panel M265

K-Number: K161573 · 2016-09-02

ApplicantMaine Molecular Quality Controls, Inc.
Decision Date2016-09-02
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FilmArray RP EZ Control Panel M265 is a medical device manufactured by Maine Molecular Quality Controls, Inc.. It received FDA 510(k) clearance on 2016-09-02 under approval number K161573. 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 RP EZ Control Panel M265?

FilmArray RP EZ Control Panel M265 is a medical device that received FDA 510(k) clearance on 2016-09-02. It is manufactured by Maine Molecular Quality Controls, Inc.. The 510(k) number is K161573.

When was FilmArray RP EZ Control Panel M265 approved by the FDA?

FilmArray RP EZ Control Panel M265 received FDA 510(k) clearance on 2016-09-02, under approval number K161573.

What company makes FilmArray RP EZ Control Panel M265?

FilmArray RP EZ Control Panel M265 is manufactured by Maine Molecular Quality Controls, Inc..

What is the FDA product code for FilmArray RP EZ Control Panel M265?

The FDA product code for FilmArray RP EZ Control Panel M265 is PMN.

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Other Devices by Maine Molecular Quality Controls, Inc.

K173171FilmArray RP2/RP2plus Control Panel K163522FilmArray Warrior Control Panel M290 K190222FilmArray Pneumonia/Pneumoniaplus Control K200010FilmArray BCID2 Control Panel M416 K202196BioFire RP2.1/RP2.1plus Control Panel M441 K203680BioFire JI Control Panel M420

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Related Devices (Code: PMN)

K152679Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPakBio-Rad Laboratories DEN150058Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPakBio-Rad Laboratories K173171FilmArray RP2/RP2plus Control PanelMaine Molecular Quality Controls, Inc. K163522FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. K182472Cepheid Xpert GBS LB Control PanelMicrobiologics, Inc. K181683BD MAX CT/GC/TV 20-Day QC PanelMicrobiologics, 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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