FDA 510(k)

MissLan® 早期检测数字早孕测试；MissLan® 早期结果数字早孕测试

K号: K251040 · 2025-09-09

申请人Guangzhou Decheng Biotechnology Co., Ltd.

决定日期2025-09-09

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

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Decheng Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-09 under 510(k) number K251040. 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 MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test?

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test is a medical device that received FDA 510(k) clearance on 2025-09-09. The listed applicant is Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K251040.

When did MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test receive FDA 510(k) clearance?

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test received FDA 510(k) clearance on 2025-09-09, under 510(k) number K251040.

Who is the listed applicant for MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test?

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

What is the FDA product code for MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test?

The FDA product code for MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test is LCX.

列明Guangzhou Decheng Biotechnology 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。

K250067Dochek®多药物尿液测试杯；Dochek®多药物尿液测试杯Pro K242428Dochek®芬太尼尿液测试条，Dochek®芬太尼尿液测试条加强版，Dochek®芬太尼尿液测试卡，Dochek®芬太尼尿液测试卡加强版，Dochek®芬太尼尿液测试杯和Dochek®芬太尼尿液测试杯加强版 K240643MissLan® 早期检测早孕试纸；MissLan® 早期检测早孕条；MissLan® 早期检测早孕中段试纸 K240698Dochek®多药物尿液测试滴卡Rx；Dochek®多药物尿液测试滴卡 K232659Dochek®多药物尿液测试杯Rx，Dochek®多药物尿液测试杯 K230038MissLan® 早孕快速测试（条），MissLan® 早孕快速测试（中段）

查看所有 8 个设备 →

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。

K251053Shinetell PlusTM 数字型早孕测试Hangzhou AllTest Biotech Co., Ltd.K250117FaStep 妊娠快速测试卡式；Fastep HCG 快速测试卡式Assure Tech., LLC K242135Synthgene家庭测试HCG测试条；Synthgene家庭测试HCG测试卡；Synthgene家庭测试HCG测试中流Nanjing Synthgene Medical Technology Co., Ltd.K243573FaStep 早期妊娠快速测试条；FaStep 早期妊娠快速测试卡式；FaStep 早期妊娠快速测试中段Assure Tech., LLC K241394iHealth® 早早孕测试；iHealth® 早早孕测试条Andon Health Co, Ltd.K240242HCG 家庭使用妊娠测试条（胶体金），HCG 家庭使用妊娠测试条（胶体金），HCG 家庭使用妊娠测试条（胶体金）Anhui Deepblue Medical Technology Co., Ltd.

官方来源

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