Source document or public record
FDA 510(k) K251526 — FilmArray GI Control Panel M238
FDA 510(k) index record K251526. Device: FilmArray GI Control Panel M238. Applicant as listed: Maine Molecular Quality Controls, Inc.. Decision date: 2025-08-14.
Source
"device_name": "FilmArray GI Control Panel M238"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K251526.
Device name: FilmArray GI Control Panel M238. Applicant as listed: Maine Molecular Quality Controls, Inc..
Decision date: 2025-08-14. Decision wording: Substantially Equivalent.
Product code: PMN. Regulation: 21 CFR 866.3920. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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