Source document or public record
FDA 510(k) K260812 — Francisella tularensis Real-time PCR Assay
FDA 510(k) index record K260812. Device: Francisella tularensis Real-time PCR Assay. Applicant as listed: Centers for Disease Control and Prevention. Decision date: 2026-03-30.
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"device_name": "Francisella tularensis Real-time PCR Assay"
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 K260812.
Device name: Francisella tularensis Real-time PCR Assay. Applicant as listed: Centers for Disease Control and Prevention.
Decision date: 2026-03-30. Decision wording: Substantially Equivalent.
Product code: SGA. Regulation: 21 CFR 866.4000. Medical specialty: Immunology.
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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