Clearance Summary
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) received FDA 510(k) clearance under submission number K263035, sponsored by Centers for Disease Control and Prevention. The device was reviewed via the Special premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2026-09-30.
- Submission: K263035
- Applicant / Sponsor: Centers for Disease Control and Prevention
- Clearance pathway: Special
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3980
- Decision date: 2026-09-30
Classification & Regulation
This clearance is catalogued under FDA product code OZE and 21 CFR 866.3980, within the Microbiology review panel as a Class II device.