FDA 510(k)

Elecsys Phospho-Tau (181P) Plasma

K号: K252163 · 2025-10-08

决定日期2025-10-08

产品代码SET

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决定实质等同

器械摘要

Elecsys Phospho-Tau (181P) Plasma is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2025-10-08 under 510(k) number K252163. The device is classified under product code SET. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elecsys Phospho-Tau (181P) Plasma?

Elecsys Phospho-Tau (181P) Plasma is a medical device that received FDA 510(k) clearance on 2025-10-08. The listed applicant is Roche Diagnostics. The 510(k) number is K252163.

When did Elecsys Phospho-Tau (181P) Plasma receive FDA 510(k) clearance?

Elecsys Phospho-Tau (181P) Plasma received FDA 510(k) clearance on 2025-10-08, under 510(k) number K252163.

Who is the listed applicant for Elecsys Phospho-Tau (181P) Plasma?

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 Elecsys Phospho-Tau (181P) Plasma?

The FDA product code for Elecsys Phospho-Tau (181P) Plasma is SET.

列明Roche Diagnostics为申报人的其他记录

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