FDA 510(k)

iHealth® 早早孕测试；iHealth® 早早孕测试条

K号: K241394 · 2024-12-20

决定日期2024-12-20

产品代码LCX

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决定实质等同

器械摘要

iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2024-12-20 under 510(k) number K241394. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip?

iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K241394.

When did iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip receive FDA 510(k) clearance?

iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip received FDA 510(k) clearance on 2024-12-20, under 510(k) number K241394.

Who is the listed applicant for iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip?

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

What is the FDA product code for iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip?

The FDA product code for iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip is LCX.

列明Andon Health 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。

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相关器械（代码：LCX）

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。

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官方来源

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