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FDA 510(k)

FilmArray RP2/RP2plus Control Panel

K-Number: K173171 · 2017-11-24

ApplicantMaine Molecular Quality Controls, Inc.
Decision Date2017-11-24
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FilmArray RP2/RP2plus Control Panel is a medical device manufactured by Maine Molecular Quality Controls, Inc.. It received FDA 510(k) clearance on 2017-11-24 under approval number K173171. 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 RP2/RP2plus Control Panel?

FilmArray RP2/RP2plus Control Panel is a medical device that received FDA 510(k) clearance on 2017-11-24. It is manufactured by Maine Molecular Quality Controls, Inc.. The 510(k) number is K173171.

When was FilmArray RP2/RP2plus Control Panel approved by the FDA?

FilmArray RP2/RP2plus Control Panel received FDA 510(k) clearance on 2017-11-24, under approval number K173171.

What company makes FilmArray RP2/RP2plus Control Panel?

FilmArray RP2/RP2plus Control Panel is manufactured by Maine Molecular Quality Controls, Inc..

What is the FDA product code for FilmArray RP2/RP2plus Control Panel?

The FDA product code for FilmArray RP2/RP2plus Control Panel is PMN.

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Other Devices by Maine Molecular Quality Controls, Inc.

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Related Devices (Code: PMN)

K161573FilmArray RP EZ Control Panel M265Maine Molecular Quality Controls, Inc. 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 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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