FDA 510(k)

MissLan® 早孕快速测试（条），MissLan® 早孕快速测试（中段）

K号: K230038 · 2023-02-28

申请人Guangzhou Decheng Biotechnology Co., Ltd.

决定日期2023-02-28

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® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) 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 2023-02-28 under 510(k) number K230038. 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® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)?

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) is a medical device that received FDA 510(k) clearance on 2023-02-28. The listed applicant is Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K230038.

When did MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) receive FDA 510(k) clearance?

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) received FDA 510(k) clearance on 2023-02-28, under 510(k) number K230038.

Who is the listed applicant for MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)?

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® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)?

The FDA product code for MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) 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。

K251040MissLan® 早期检测数字早孕测试；MissLan® 早期结果数字早孕测试 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

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。

K251040MissLan® 早期检测数字早孕测试；MissLan® 早期结果数字早孕测试Guangzhou Decheng Biotechnology Co., Ltd.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.

官方来源

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