FDA 510(k)

AssureTech 面板浸入测试，AssureTech 快速杯测试

K号: K181768 · 2018-08-20

决定日期2018-08-20

产品代码NFT

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决定实质等同

器械摘要

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests 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 2018-08-20 under 510(k) number K181768. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AssureTech Panel Dip Tests, AssureTech Quick Cup Tests?

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests is a medical device that received FDA 510(k) clearance on 2018-08-20. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K181768.

When did AssureTech Panel Dip Tests, AssureTech Quick Cup Tests receive FDA 510(k) clearance?

AssureTech Panel Dip Tests, AssureTech Quick Cup Tests received FDA 510(k) clearance on 2018-08-20, under 510(k) number K181768.

Who is the listed applicant for AssureTech Panel Dip Tests, AssureTech Quick Cup Tests?

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 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests?

The FDA product code for AssureTech Panel Dip Tests, AssureTech Quick Cup Tests is NFT.

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。

K233174FaStep® 妊娠快速测试条；FaStep® 妊娠快速测试中段 K201630AssureTech DOA 浸入式条形码筛查面板测试，AssureTech DOA 集成杯测试 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：NFT）

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。

K261409BioTeke® 多药物尿液检测杯Bioteke Corporation (Wuxi) Co., Ltd.K261984AssureTech 快速杯测试；AssureTech 多药物尿液测试杯Assure Tech., LLC K261280BioSieve多药物尿液测试板；BioSieve多药物尿液家庭测试板Vivachek Biotech (Hangzhou) Co., Ltd.K260065SAFElife T-Dip多药物尿液测试板；SAFElife T-Dip多药物尿液测试板 DxGuangzhou Wondfo Biotech Co., Ltd.K260355Webest 多药物尿液杯；Webest 家庭多药物尿液杯WEBEST Biotech,, LLC K252550SAFElife T-Cup多药物尿液测试杯；SAFElife T-Cup多药物尿液测试杯 DxGuangzhou Wondfo Biotech Co., Ltd.

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。