FDA 510(k)

用于SPAPLUS的类风湿因子（RF）试剂盒

K号: K160070 · 2016-12-07

决定日期2016-12-07

产品代码DHR

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决定实质等同

器械摘要

Rheumatoid Factor (RF) Kit for use on SPAPLUS is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2016-12-07 under 510(k) number K160070. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Rheumatoid Factor (RF) Kit for use on SPAPLUS?

Rheumatoid Factor (RF) Kit for use on SPAPLUS is a medical device that received FDA 510(k) clearance on 2016-12-07. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K160070.

When did Rheumatoid Factor (RF) Kit for use on SPAPLUS receive FDA 510(k) clearance?

Rheumatoid Factor (RF) Kit for use on SPAPLUS received FDA 510(k) clearance on 2016-12-07, under 510(k) number K160070.

Who is the listed applicant for Rheumatoid Factor (RF) Kit for use on SPAPLUS?

The FDA 510(k) record lists The Binding Site Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rheumatoid Factor (RF) Kit for use on SPAPLUS?

The FDA product code for Rheumatoid Factor (RF) Kit for use on SPAPLUS is DHR.

列明The Binding Site Group , Ltd.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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