FDA 510(k)

Healgen® 准确度口腔液体药物测试，Healgen® 准确度口腔液体药物测试 COT

K号: K223162 · 2023-03-17

决定日期2023-03-17

产品代码LDJ

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® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT 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 2023-03-17 under 510(k) number K223162. The device is classified under product code LDJ. 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 COT?

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K223162.

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

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT received FDA 510(k) clearance on 2023-03-17, under 510(k) number K223162.

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

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, Healgen® Accurate Oral Fluid Drug Test COT?

The FDA product code for Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT is LDJ.

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 K253567Healgen 准确尿液药物筛查条；Healgen 准确家庭尿液药物测试条 K251800Healgen® URS 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)

查看所有 15 个设备 →

相关器械（代码：LDJ）

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。

K232732Rapid 毒品（THC）测试条 20，Rapid 毒品（THC）测试浸卡 20，Rapid 毒品（THC）测试条 50，Rapid 毒品（THC）测试浸卡 50Co-Innovation Biotech Co., Ltd.K232604LYHER® 尿液大麻（THC）测试套件（条），LYHER® 尿液大麻（THC）测试套件（卡式）Hangzhou Laihe Biotech Co., Ltd.K192515BIOEASY大麻测试浸纸卡40，BIOEASY大麻测试浸纸卡20，BIOEASY大麻测试条40，BIOEASY大麻测试条20Shenzhen Bioeasy Biotechnology Co., Ltd.K153741CLUNGENE 甲基安非他命测试，CLUNGENE 吗啡测试，CLUNGENE 大麻测试Hangzhou Clongene Biotech Co., Ltd.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。