FDA 510(k)

AssureTech DOA 浸入式条形码筛查面板测试，AssureTech DOA 集成杯测试

K号: K201630 · 2021-08-12

决定日期2021-08-12

产品代码DJG

咨询委员会TX 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated 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 2021-08-12 under 510(k) number K201630. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests?

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests is a medical device that received FDA 510(k) clearance on 2021-08-12. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K201630.

When did AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests receive FDA 510(k) clearance?

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests received FDA 510(k) clearance on 2021-08-12, under 510(k) number K201630.

Who is the listed applicant for AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated 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 DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests?

The FDA product code for AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests is DJG.

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 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 →

官方来源

在 FDA 数据库中查看 →

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。