Source document or public record
FDA 510(k) K191161 — xTAG Gastrointestinal Pathogen Panel (GPP)
FDA 510(k) index record K191161. Device: xTAG Gastrointestinal Pathogen Panel (GPP). Applicant as listed: Luminex Molecular Diagnostics, Inc.. Decision date: 2019-11-12.
Source
"device_name": "xTAG Gastrointestinal Pathogen Panel (GPP)"
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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2026-10-20
2026-10-20
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FDA 510(k) public index record K191161.
Device name: xTAG Gastrointestinal Pathogen Panel (GPP). Applicant as listed: Luminex Molecular Diagnostics, Inc..
Decision date: 2019-11-12. Decision wording: Substantially Equivalent.
Product code: PCH. Regulation: 21 CFR 866.3990. 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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