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FDA 510(k)

BIO-VENTURE快速多药物测试简易杯非处方药使用，BIO-VENTURE快速多药物测试分割键杯非处方药使用，BIO-VENTURE快速多药物测试简易杯处方药使用，BIO-VENTURE快速多药物测试分割键杯处方药使用

K号: K180879 · 2018-12-14

申请人Shanghai Venture Bio-Tech Co., Ltd.
决定日期2018-12-14
产品代码DKZ
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

BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Venture Bio-Tech Co., Ltd.. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K180879. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use?

BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Shanghai Venture Bio-Tech Co., Ltd.. The 510(k) number is K180879.

When did BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use receive FDA 510(k) clearance?

BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use received FDA 510(k) clearance on 2018-12-14, under 510(k) number K180879.

Who is the listed applicant for BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use?

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

What is the FDA product code for BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use?

The FDA product code for BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use is DKZ.

相关临床试验

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。

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Shanghai Venture Bio-Tech 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。

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

相关器械（代码：DKZ）

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。

K240670DRI 摇滚药检测Microgenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta药物筛查杯，Xenta药物筛查滴卡Xenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX 药物筛查，94600Quidel Cardiovascular, Inc.K191099Atlas 多药物筛查测试杯，Atlas 多药物筛查测试板Atlas MedicalK182719Quidel Triage TOX 药物筛查，94600；Quidel Triage® MeterProQuidel Cardiovascular, Inc.

官方来源

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