FDA 510(k)

FaStep® 妊娠快速测试条；FaStep® 妊娠快速测试中段

K号: K233174 · 2024-02-05

决定日期2024-02-05

产品代码LCX

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决定实质等同

器械摘要

FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. It received FDA 510(k) clearance on 2024-02-05 under 510(k) number K233174. 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 FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream?

FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream is a medical device that received FDA 510(k) clearance on 2024-02-05. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K233174.

When did FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream receive FDA 510(k) clearance?

FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream received FDA 510(k) clearance on 2024-02-05, under 510(k) number K233174.

Who is the listed applicant for FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream?

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

What is the FDA product code for FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream?

The FDA product code for FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream is LCX.

列明Assure Tech. (Hangzhou) 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。

K201630AssureTech DOA 浸入式条形码筛查面板测试，AssureTech DOA 集成杯测试 K181768AssureTech 面板浸入测试，AssureTech 快速杯测试 K180349AssureTech 面板浸入测试，AssureTech 快速杯测试 K170049AssureTech 面板浸入测试，AssureTech 快速杯测试 K161044AssureTech 甲基安非他命测试（条形码，面板浸入，快速杯，一键式分割杯），AssureTech 苯环己哌啶测试（条形码，面板浸入，快速杯，一键式分割杯），AssureTech 大麻测试（条形码，面板浸入，快速杯，一键式分割杯）K153465AssureTech 安非他命测试（条形码，浸卡，快速杯，一键式分割杯），AssureTech 可卡因测试（条形码，浸卡，快速杯，一键式分割杯），AssureTech 吗啡测试（条形码，浸卡，快速杯，一键式分割杯）

查看所有 7 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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