FDA 510(k)

Healgen 多药物尿液测试杯；Healgen 多药物尿液测试条

K号: K163704 · 2017-08-02

决定日期2017-08-02

产品代码JXM

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决定实质等同

器械摘要

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card 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 2017-08-02 under 510(k) number K163704. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card?

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card is a medical device that received FDA 510(k) clearance on 2017-08-02. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K163704.

When did Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card receive FDA 510(k) clearance?

Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card received FDA 510(k) clearance on 2017-08-02, under 510(k) number K163704.

Who is the listed applicant for Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card?

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 Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card?

The FDA product code for Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card is JXM.

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。

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