K253318
- 510(k) number
- K253318
- Device name
- Clungene RSV Antigen Rapid Test
- Applicant
- Hangzhou Clongene Biotech Co., Ltd. CN
- Product code
- GQG — Antigen, Cf (Including Cf Controls), Respiratory Syn
- Decision date
- 2026-01-30
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K253318.pdf
Official FDA record: K253318
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.