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FDA 510(k)

EGENS妊娠测试中流I，EGENS妊娠测试中流II

K号: K232864 · 2024-01-26

申请人Nantong Egens Biotechnology Co., Ltd.
决定日期2024-01-26
产品代码LCX
咨询委员会CH 请注意，您提供的文本“CH”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

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II is the device name listed in this FDA 510(k) record. The listed applicant is Nantong Egens Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K232864. 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 EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II?

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Nantong Egens Biotechnology Co., Ltd.. The 510(k) number is K232864.

When did EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II receive FDA 510(k) clearance?

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II received FDA 510(k) clearance on 2024-01-26, under 510(k) number K232864.

Who is the listed applicant for EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II?

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

What is the FDA product code for EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II?

The FDA product code for EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II is LCX.

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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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