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FDA 510(k)

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K号: K161044 · 2016-07-06

申请人Assure Tech. (Hangzhou) Co, Ltd.
决定日期2016-07-06
产品代码DJC
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 Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) 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 2016-07-06 under 510(k) number K161044. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)?

AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K161044.

When did AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) receive FDA 510(k) clearance?

AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) received FDA 510(k) clearance on 2016-07-06, under 510(k) number K161044.

Who is the listed applicant for AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)?

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 Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)?

The FDA product code for AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) is DJC.

相关临床试验

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NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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：DJC）

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。

K253705Healgen® 准确度 口腔液体药物测试Healgen Scientific,, LLCK240287LYHER® 口腔液体多药物测试套件（Cube）Hangzhou Laihe Biotech Co., Ltd.K180878BIO-VENTURE快速非处方药阿片类药物测试条，BIO-VENTURE快速非处方药奥沙西泮测试条，BIO-VENTURE快速非处方药可卡因测试条，BIO-VENTURE快速非处方药甲基苯丙胺测试条，BIO-VENTURE快速非处方药吗啡测试条，BIO-VENTURE快速非处方药大麻测试条，BIO-VENTURE快速处方药阿片类药物测试条，BIO-VENTURE快速处方药奥沙西泮测试条，BIO-VENTURE快速处方药可卡因测试条Shanghai Venture Bio-Tech Co., Ltd.K181305OralTox 口腔液体药物测试Premier Biotech, Inc.K171403OralTox 口腔液体药物测试Premier Biotech, Inc.

官方来源

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