FDA 510(k)

FilmArray 胃肠道控制面板 M238

K号: K251526 · 2025-08-14

申请人Maine Molecular Quality Controls, Inc.

决定日期2025-08-14

产品代码PMN

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决定实质等同

器械摘要

FilmArray GI Control Panel M238 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 2025-08-14 under 510(k) number K251526. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K251526.

When did FilmArray GI Control Panel M238 receive FDA 510(k) clearance?

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

Who is the listed applicant for FilmArray GI Control Panel M238?

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 GI Control Panel M238?

The FDA product code for FilmArray GI Control Panel M238 is PMN.

列明Maine Molecular Quality Controls, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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