FDA 510(k)

Wondfo 2019-nCoV 抗原检测（侧流法）

K号: K241317 · 2024-09-30

决定日期2024-09-30

产品代码QYT

咨询委员会抱歉，您提供的内容“MI”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-09-30 under 510(k) number K241317. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)?

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a medical device that received FDA 510(k) clearance on 2024-09-30. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K241317.

When did Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) receive FDA 510(k) clearance?

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) received FDA 510(k) clearance on 2024-09-30, under 510(k) number K241317.

Who is the listed applicant for Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)?

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

What is the FDA product code for Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)?

The FDA product code for Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is QYT.

列明Guangzhou Wondfo 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。

K260065SAFElife T-Dip多药物尿液测试板；SAFElife T-Dip多药物尿液测试板 Dx K252550SAFElife T-Cup多药物尿液测试杯；SAFElife T-Cup多药物尿液测试杯 Dx K251289WELLlife 新冠抗原检测处方 K241741SAFElife™芬太尼尿液家庭测试（条）；SAFElife™芬太尼（FTY）尿液测试条；SAFElife™ T-Dip芬太尼尿液家庭测试（滴卡）；SAFElife™ T-Dip芬太尼（FTY）尿液测试板 K202567Wondfo T-Dip 多药物尿液检测板，Wondfo T-Dip 多药物尿液检测板 Rx K182701Wondfo T-Cup 多药物尿液检测杯

查看所有 10 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。