FDA 510(k)

BioSieve™芬太尼FIA测试套件；BioSieve™ ToxiSmart FIA阅读器

K号: K240124 · 2024-06-14

申请人Vivachek Biotech (Hangzhou) Co., Ltd.

决定日期2024-06-14

产品代码DJG

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决定实质等同

器械摘要

BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader is the device name listed in this FDA 510(k) record. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2024-06-14 under 510(k) number K240124. 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 BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader?

BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K240124.

When did BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader receive FDA 510(k) clearance?

BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader received FDA 510(k) clearance on 2024-06-14, under 510(k) number K240124.

Who is the listed applicant for BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader?

The FDA 510(k) record lists Vivachek Biotech (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader?

The FDA product code for BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader is DJG.

列明Vivachek Biotech (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。

K261280BioSieve多药物尿液测试板；BioSieve多药物尿液家庭测试板 K252554Wisdiag 多药物尿液检测杯；Wisdiag 多药物尿液家庭检测杯 K241869BioSieve™芬太尼FIA家庭测试套件；BioSieve™芬太尼FIA专业测试套件；BioSieve™ Toxismart阅读器 K222126VivaChek™ Fad 血糖监测系统，VivaChek™ Fad 智能血糖监测系统，VivaChek™ Fad 同步血糖监测系统 K233058VivaChek Link Plus 血糖监测系统 K233062BioSieve™ 多药物尿液测试板；BioSieve™ 多药物尿液测试板Rx

查看所有 10 个设备 →

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 Limited K253082LZI 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 Corporation K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)测试套件 - 定性；Healgen® 免疫荧光分析仪 (OG-H180)Healgen Scientific,, LLC K251634LZI 芬太尼 III 酶联免疫测定Lin-Zhi International, Inc.

官方来源

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