Documento fuente o registro público
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.
Fuente
"device_name": "Francisella tularensis Real-time PCR Assay"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-23
professional use
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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.