Clungene RSV Antigen Rapid Test— 510(k) K253318

Substantially Equivalent

Hangzhou Clongene Biotech Co., Ltd.

FDA 510(k) clearance K253318 for Clungene RSV Antigen Rapid Test, Substantially Equivalent on 2026-01-30. Applicant: Hangzhou Clongene Biotech Co., Ltd..

Clearance details

Applicant: Hangzhou Clongene Biotech Co., Ltd.
Product code: Code GQG
Advisory panel: Microbiology
Date received: 2025-09-30
Decision date: 2026-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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