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FDA 510(k)

FilmArray GI Control Panel M238

K-Number: K251526 · 2025-08-14

ApplicantMaine Molecular Quality Controls, Inc.
Decision Date2025-08-14
Product CodePMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FilmArray GI Control Panel M238 is a medical device manufactured by Maine Molecular Quality Controls, Inc.. It received FDA 510(k) clearance on 2025-08-14 under approval number K251526. 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 GI Control Panel M238?

FilmArray GI Control Panel M238 is a medical device that received FDA 510(k) clearance on 2025-08-14. It is manufactured by Maine Molecular Quality Controls, Inc.. The 510(k) number is K251526.

When was FilmArray GI Control Panel M238 approved by the FDA?

FilmArray GI Control Panel M238 received FDA 510(k) clearance on 2025-08-14, under approval number K251526.

What company makes FilmArray GI Control Panel M238?

FilmArray GI Control Panel M238 is manufactured by Maine Molecular Quality Controls, Inc..

What is the FDA product code for FilmArray GI Control Panel M238?

The FDA product code for FilmArray GI Control Panel M238 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. K163522FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. K182472Cepheid Xpert GBS LB Control 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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