Clearance Summary
Francisella tularensis Real-time PCR assay received FDA 510(k) clearance under submission number K252072, sponsored by Centers for Disease Control and Prevention. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2025-09-30.
- Submission: K252072
- Applicant / Sponsor: Centers for Disease Control and Prevention
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.4000
- Decision date: 2025-09-30
Classification & Regulation
This clearance is catalogued under FDA product code SGA and 21 CFR 866.4000, within the Immunology review panel as a Class II device.