Source document or public record
FDA 510(k) K193167 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
FDA 510(k) index record K193167. Device: NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software. Applicant as listed: Luminex Molecular Diagnostics, Inc.. Decision date: 2019-12-11.
Source
"device_name": "NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software"
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 K193167.
Device name: NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software. Applicant as listed: Luminex Molecular Diagnostics, Inc..
Decision date: 2019-12-11. Decision wording: Substantially Equivalent.
Product code: OCC. Regulation: 21 CFR 866.3980. 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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