FDA 510(k)

UASure II 血尿酸监测系统

K号: K242209 · 2025-04-04

决定日期2025-04-04

产品代码PTC

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决定实质等同

器械摘要

UASure II Blood Uric Acid Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K242209. The device is classified under product code PTC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the UASure II Blood Uric Acid Monitoring System?

UASure II Blood Uric Acid Monitoring System is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K242209.

When did UASure II Blood Uric Acid Monitoring System receive FDA 510(k) clearance?

UASure II Blood Uric Acid Monitoring System received FDA 510(k) clearance on 2025-04-04, under 510(k) number K242209.

Who is the listed applicant for UASure II Blood Uric Acid Monitoring System?

The FDA 510(k) record lists Apex BioTechnology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UASure II Blood Uric Acid Monitoring System?

The FDA product code for UASure II Blood Uric Acid Monitoring System is PTC.

列明Apex BioTechnology Corp.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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官方来源

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