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FDA 510(k)

Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)测试套件 - 定性；Healgen® 免疫荧光分析仪 (OG-H180)

K号: K251972 · 2025-08-15

申请人Healgen Scientific,, LLC
决定日期2025-08-15
产品代码DJG
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

Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) is the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K251972. 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 Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)?

Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K251972.

When did Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) receive FDA 510(k) clearance?

Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) received FDA 510(k) clearance on 2025-08-15, under 510(k) number K251972.

Who is the listed applicant for Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)?

The FDA 510(k) record lists Healgen Scientific,, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)?

The FDA product code for Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) 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。

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列明Healgen Scientific,, LLC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。

K260095Heal-Check 快速COVID-19抗原自测K253705Healgen® 准确度 口腔液体药物测试K252523Healgen® 准确度 口腔液体药物测试 COT/THC；Healgen® 准确度 口腔液体药物测试K251800Healgen® URS 测试条K253567Healgen 准确尿液药物筛查条；Healgen 准确家庭尿液药物测试条K243365Healgen 准确多药物尿液药物筛查杯；Healgen 准确家庭多药物尿液测试杯

查看所有 15 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 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 CorporationK251634LZI 芬太尼 III 酶联免疫测定Lin-Zhi International, Inc.K240124BioSieve™芬太尼FIA测试套件；BioSieve™ ToxiSmart FIA阅读器Vivachek Biotech (Hangzhou) Co., Ltd.

官方来源

在 FDA 数据库中查看 →

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