FDA 510(k)

ARK 氢可酮测定法

K号: K231752 · 2023-11-09

决定日期2023-11-09

产品代码DJG

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决定实质等同

器械摘要

ARK Hydrocodone Assay is the device name listed in this FDA 510(k) record. The listed applicant is Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K231752. 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 ARK Hydrocodone Assay?

ARK Hydrocodone Assay is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Ark Diagnostics, Inc.. The 510(k) number is K231752.

When did ARK Hydrocodone Assay receive FDA 510(k) clearance?

ARK Hydrocodone Assay received FDA 510(k) clearance on 2023-11-09, under 510(k) number K231752.

Who is the listed applicant for ARK Hydrocodone Assay?

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

What is the FDA product code for ARK Hydrocodone Assay?

The FDA product code for ARK Hydrocodone Assay is DJG.

列明Ark Diagnostics, 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。

K232522ARK 左乙拉西坦II测定法 K232017ARK 甲氨蝶呤II测定法 K201089ARK 拉考沙胺测定法 K200197ARK 芬太尼II测定法 K182280ARK 曲马多检测 K182779ARK EDDP 测定法

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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