Cleared Traditional

Clungene RSV Antigen Rapid Test

K253318 · Hangzhou Clongene Biotech Co., Ltd. · Microbiology

Jan 2026

Decision

122d

Days

Class 1

Risk

About This 510(k) Submission

K253318 is an FDA 510(k) clearance for the Clungene RSV Antigen Rapid Test, a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I — General Controls, product code GQG), submitted by Hangzhou Clongene Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on January 30, 2026, 122 days after receiving the submission on September 30, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.

Submission Details

510(k) Number	K253318 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2025
Decision Date	January 30, 2026
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	GQG — Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
Device Class	Class I — General Controls
CFR Regulation	21 CFR 866.3480