FDA 510(k)

WELLlife™ COVID-19 / 流感A&B 家庭检测；WELLlife™ COVID-19 / 流感A&B 抗原检测

K号: K243256 · 2025-01-16

决定日期2025-01-16

产品代码SCA

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决定实质等同

器械摘要

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest is the device name listed in this FDA 510(k) record. The listed applicant is Wondfo USA Co, Ltd.. It received FDA 510(k) clearance on 2025-01-16 under 510(k) number K243256. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest?

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Wondfo USA Co, Ltd.. The 510(k) number is K243256.

When did WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest receive FDA 510(k) clearance?

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest received FDA 510(k) clearance on 2025-01-16, under 510(k) number K243256.

Who is the listed applicant for WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest?

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

What is the FDA product code for WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest?

The FDA product code for WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest is SCA.

列明Wondfo USA 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。

K251563WELLlife 流感A&B家用检测仪；WELLlife 流感A&B检测仪

相关器械（代码：SCA）

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。

K261212Flowflex Plus RSV + 流感A/B + COVID快速测试ACON Laboratories, Inc.K251085iHealth流感A&B/COVID-19/RSV快速检测；iHealth流感A&B/COVID-19/RSV快速检测专业版Ihealth Labs, Inc.K251092iHealth 流感A&B/COVID-19 快速测试；iHealth 流感A&B/COVID-19 快速测试专业版Ihealth Labs, Inc.K251538Status® COVID-19/流感A&BPrinceton BioMeditech Corp.K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc.K251604CareSuperb COVID-19/流感 A&B 抗原组合家用检测Access Bio, Inc.

官方来源

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