FDA 510(k)

ASI 自动化 ASI RPR 测试，用于梅毒的 ASI Evolution

K号: K182391 · 2018-11-30

决定日期2018-11-30

产品代码GMQ

咨询委员会抱歉，您提供的内容“MI”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution is the device name listed in this FDA 510(k) record. The listed applicant is Arlington Scientific, Inc. (Asi). It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K182391. The device is classified under product code GMQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ASI Automated ASI RPR Test for Syphilis on the ASI Evolution?

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Arlington Scientific, Inc. (Asi). The 510(k) number is K182391.

When did ASI Automated ASI RPR Test for Syphilis on the ASI Evolution receive FDA 510(k) clearance?

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution received FDA 510(k) clearance on 2018-11-30, under 510(k) number K182391.

Who is the listed applicant for ASI Automated ASI RPR Test for Syphilis on the ASI Evolution?

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

What is the FDA product code for ASI Automated ASI RPR Test for Syphilis on the ASI Evolution?

The FDA product code for ASI Automated ASI RPR Test for Syphilis on the ASI Evolution is GMQ.

列明Arlington Scientific, Inc. (Asi)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。

K201438ASI 自动化 RPR（快速血浆反应素）梅毒测试，用于 ASI Evolution 自动梅毒分析仪 K173376ASI Evolution

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。