FDA 510(k)

Instant-view-PLUS immunochemical Fecal Occult Blood Test

K号: K173212 · 2018-02-15

决定日期2018-02-15

产品代码KHE

咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Instant-view-PLUS immunochemical Fecal Occult Blood Test is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Scientific Designs, Inc.. It received FDA 510(k) clearance on 2018-02-15 under 510(k) number K173212. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Instant-view-PLUS immunochemical Fecal Occult Blood Test?

Instant-view-PLUS immunochemical Fecal Occult Blood Test is a medical device that received FDA 510(k) clearance on 2018-02-15. The listed applicant is Alfa Scientific Designs, Inc.. The 510(k) number is K173212.

When did Instant-view-PLUS immunochemical Fecal Occult Blood Test receive FDA 510(k) clearance?

Instant-view-PLUS immunochemical Fecal Occult Blood Test received FDA 510(k) clearance on 2018-02-15, under 510(k) number K173212.

Who is the listed applicant for Instant-view-PLUS immunochemical Fecal Occult Blood Test?

FDA 510(k)记录中列出Alfa Scientific Designs, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Instant-view-PLUS immunochemical Fecal Occult Blood Test?

The FDA product code for Instant-view-PLUS immunochemical Fecal Occult Blood Test is KHE.

列明Alfa Scientific Designs, Inc.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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