FDA 510(k)

Xenta药物筛查杯，Xenta药物筛查滴卡

K号: K222955 · 2023-02-06

决定日期2023-02-06

产品代码DJG

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决定实质等同

器械摘要

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard is the device name listed in this FDA 510(k) record. The listed applicant is Xenta Biomedical Science Co., Ltd.. It received FDA 510(k) clearance on 2023-02-06 under 510(k) number K222955. 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 Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard is a medical device that received FDA 510(k) clearance on 2023-02-06. The listed applicant is Xenta Biomedical Science Co., Ltd.. The 510(k) number is K222955.

When did Xenta Drug Screen Cup, Xenta Drug Screen Dipcard receive FDA 510(k) clearance?

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard received FDA 510(k) clearance on 2023-02-06, under 510(k) number K222955.

Who is the listed applicant for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

The FDA 510(k) record lists Xenta Biomedical Science Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard?

The FDA product code for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard is DJG.

列明Xenta Biomedical Science 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。

K231137Xenta药物筛查杯，Xenta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 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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