FDA 510(k)

Healgen® 准确度口腔液体药物测试

K号: K253705 · 2026-03-16

决定日期2026-03-16

产品代码DJC

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决定实质等同

器械摘要

Healgen® Accurate Oral Fluid Drug Test 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 2026-03-16 under 510(k) number K253705. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Healgen® Accurate Oral Fluid Drug Test?

Healgen® Accurate Oral Fluid Drug Test is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K253705.

When did Healgen® Accurate Oral Fluid Drug Test receive FDA 510(k) clearance?

Healgen® Accurate Oral Fluid Drug Test received FDA 510(k) clearance on 2026-03-16, under 510(k) number K253705.

Who is the listed applicant for Healgen® Accurate Oral Fluid Drug Test?

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® Accurate Oral Fluid Drug Test?

The FDA product code for Healgen® Accurate Oral Fluid Drug Test is DJC.

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 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 K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)测试套件 - 定性；Healgen® 免疫荧光分析仪 (OG-H180)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：DJC）

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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