FDA 510(k)

用于SPAPLUS的C-反应蛋白试剂盒

K号: K161982 · 2017-04-05

决定日期2017-04-05

产品代码DCN

咨询委员会抱歉，您提供的信息不完整，无法进行翻译。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

C-Reactive Protein Kit for use on SPAPLUS is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group. It received FDA 510(k) clearance on 2017-04-05 under 510(k) number K161982. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the C-Reactive Protein Kit for use on SPAPLUS?

C-Reactive Protein Kit for use on SPAPLUS is a medical device that received FDA 510(k) clearance on 2017-04-05. The listed applicant is The Binding Site Group. The 510(k) number is K161982.

When did C-Reactive Protein Kit for use on SPAPLUS receive FDA 510(k) clearance?

C-Reactive Protein Kit for use on SPAPLUS received FDA 510(k) clearance on 2017-04-05, under 510(k) number K161982.

Who is the listed applicant for C-Reactive Protein Kit for use on SPAPLUS?

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

What is the FDA product code for C-Reactive Protein Kit for use on SPAPLUS?

The FDA product code for C-Reactive Protein Kit for use on SPAPLUS is DCN.

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。

用于SPAPLUS的C-反应蛋白试剂盒

器械摘要

常见问题

相关临床试验

相关器械（代码：DCN）

官方来源