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FDA 510(k)

ATTEST 药物筛查杯，ATTEST 药物筛查滴卡

K号: K182123 · 2019-03-29

申请人Advin Biotech, Inc.
决定日期2019-03-29
产品代码DJG
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决定实质等同

器械摘要

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card is the device name listed in this FDA 510(k) record. The listed applicant is Advin Biotech, Inc.. It received FDA 510(k) clearance on 2019-03-29 under 510(k) number K182123. 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 ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card?

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card is a medical device that received FDA 510(k) clearance on 2019-03-29. The listed applicant is Advin Biotech, Inc.. The 510(k) number is K182123.

When did ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card receive FDA 510(k) clearance?

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card received FDA 510(k) clearance on 2019-03-29, under 510(k) number K182123.

Who is the listed applicant for ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card?

The FDA 510(k) record lists Advin Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card?

The FDA product code for ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card is DJG.

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Advin Biotech, Inc.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。

K252867VINScreen 尿液药物检测杯；VINScreen 尿液药物家用检测杯K201494ATTEST 药物筛查杯，ATTEST 药物筛查滴卡

相关器械（代码：DJG）

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。

K252684Labcorp 芬太尼 尿液视觉测试Medtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA尿液多联检测Randox Laboratories LimitedK253082LZI 布托啡诺 II 酶联免疫测定Lin-Zhi International, Inc.K252520SEFRIA® 水合吗啡口腔液体Immunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)测试套件 - 定性；Healgen® 免疫荧光分析仪 (OG-H180)Healgen Scientific,, LLCK251634LZI 芬太尼 III 酶联免疫测定Lin-Zhi International, Inc.

官方来源

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