FDA 510(k)

Clungene RSV 抗原快速检测

K号: K253318 · 2026-01-30

决定日期2026-01-30

产品代码GQG

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决定实质等同

器械摘要

Clungene RSV Antigen Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-01-30 under 510(k) number K253318. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Clungene RSV Antigen Rapid Test?

Clungene RSV Antigen Rapid Test is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K253318.

When did Clungene RSV Antigen Rapid Test receive FDA 510(k) clearance?

Clungene RSV Antigen Rapid Test received FDA 510(k) clearance on 2026-01-30, under 510(k) number K253318.

Who is the listed applicant for Clungene RSV Antigen Rapid Test?

The FDA 510(k) record lists Hangzhou Clongene Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clungene RSV Antigen Rapid Test?

The FDA product code for Clungene RSV Antigen Rapid Test is GQG.

列明Hangzhou Clongene Biotech Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252118CLUNGENE 多药物测试简易杯；CLUNGENE 多药物家庭测试简易杯 K242802CLUNGENE 芬太尼家庭测试条；CLUNGENE 芬太尼测试条 K193132CLUNGENE HCG 孕检快速测试条，CLUNGENE HCG 孕检快速测试条，CLUNGENE HCG 孕检快速测试中段 K190412CLUNGENE 多药物测试滴卡，CLUNGENE 多药物测试简易杯 K181790CLUNGENE 多药物测试滴卡，CLUNGENE 多药物测试简易杯 K180255CLUNGENE 多药物测试滴卡，CLUNGENE 多药物测试简易杯

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