Clearance Summary
Clungene RSV Antigen Rapid Test received FDA 510(k) clearance under submission number K253318, sponsored by Hangzhou Clongene Biotech Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2026-01-30.
- Submission: K253318
- Applicant / Sponsor: Hangzhou Clongene Biotech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class I
- Regulation citation: 21 CFR 866.3480
- Decision date: 2026-01-30
Classification & Regulation
This clearance is catalogued under FDA product code GQG and 21 CFR 866.3480, within the Microbiology review panel as a Class I device.