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FDA 510(k)

FilmArray Warrior Control Panel M290

K-Number: K163522 · 2017-03-14

ApplicantMaine Molecular Quality Controls, Inc.
Decision Date2017-03-14
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FilmArray Warrior Control Panel M290 is a medical device manufactured by Maine Molecular Quality Controls, Inc.. It received FDA 510(k) clearance on 2017-03-14 under approval number K163522. 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 Warrior Control Panel M290?

FilmArray Warrior Control Panel M290 is a medical device that received FDA 510(k) clearance on 2017-03-14. It is manufactured by Maine Molecular Quality Controls, Inc.. The 510(k) number is K163522.

When was FilmArray Warrior Control Panel M290 approved by the FDA?

FilmArray Warrior Control Panel M290 received FDA 510(k) clearance on 2017-03-14, under approval number K163522.

What company makes FilmArray Warrior Control Panel M290?

FilmArray Warrior Control Panel M290 is manufactured by Maine Molecular Quality Controls, Inc..

What is the FDA product code for FilmArray Warrior Control Panel M290?

The FDA product code for FilmArray Warrior Control Panel M290 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 K173171FilmArray RP2/RP2plus Control PanelMaine 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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