K260812
- 510(k) number
- K260812
- Device name
- Francisella tularensis Real-time PCR Assay
- Applicant
- Centers for Disease Control and Prevention GA · US
- Product code
- SGA — Biothreat Microbial Agent Nucleic Acid Detection Tes
- Decision date
- 2026-03-30
- Date received
- 2026-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K260812.pdf
Official FDA record: K260812
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.