FDA 510(k)

CoaguChek XS Plus 系统

K号: K253188 · 2025-10-24

决定日期2025-10-24

产品代码GJS

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决定实质等同

器械摘要

CoaguChek XS Plus System is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K253188. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CoaguChek XS Plus System?

CoaguChek XS Plus System is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Roche Diagnostics. The 510(k) number is K253188.

When did CoaguChek XS Plus System receive FDA 510(k) clearance?

CoaguChek XS Plus System received FDA 510(k) clearance on 2025-10-24, under 510(k) number K253188.

Who is the listed applicant for CoaguChek XS Plus System?

FDA 510(k)记录显示罗氏诊断公司为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for CoaguChek XS Plus System?

The FDA product code for CoaguChek XS Plus System is GJS.

列明Roche Diagnostics为申报人的其他记录

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