K252072
- 510(k) number
- K252072
- 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
- 2025-09-30
- Date received
- 2025-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252072.pdf
Official FDA record: K252072
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.