Source document or public record
FDA 510(k) K231758 — NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
FDA 510(k) index record K231758. Device: NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2). Applicant as listed: Luminex Molecular Diagnostics, Inc.. Decision date: 2024-03-11.
Source
"device_name": "NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K231758.
Device name: NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2). Applicant as listed: Luminex Molecular Diagnostics, Inc..
Decision date: 2024-03-11. Decision wording: Substantially Equivalent.
Product code: QOF. Regulation: 21 CFR 866.3981. 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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