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FDA 510(k)

Macro & Micro-Test HCG 孕检试纸条

K号: K230741 · 2023-10-13

申请人Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
决定日期2023-10-13
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

Macro & Micro-Test HCG Pregnancy Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K230741. 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 Macro & Micro-Test HCG Pregnancy Test Midstream?

Macro & Micro-Test HCG Pregnancy Test Midstream is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.. The 510(k) number is K230741.

When did Macro & Micro-Test HCG Pregnancy Test Midstream receive FDA 510(k) clearance?

Macro & Micro-Test HCG Pregnancy Test Midstream received FDA 510(k) clearance on 2023-10-13, under 510(k) number K230741.

Who is the listed applicant for Macro & Micro-Test HCG Pregnancy Test Midstream?

The FDA 510(k) record lists Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Macro & Micro-Test HCG Pregnancy Test Midstream?

The FDA product code for Macro & Micro-Test HCG Pregnancy Test Midstream 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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