Source document or public record
FDA 510(k) K242465 — Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
FDA 510(k) index record K242465. Device: Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. Applicant as listed: Hologic, Inc.. Decision date: 2024-11-15.
Source
"device_name": "Panther Fusion SARS-CoV-2/Flu A/B/RSV assay"
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
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FDA 510(k) public index record K242465.
Device name: Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. Applicant as listed: Hologic, Inc..
Decision date: 2024-11-15. 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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