FDA 510(k)

Tina-quant心脏高敏CRP III

K号: K260026 · 2026-04-02

决定日期2026-04-02

产品代码NQD

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决定实质等同

器械摘要

Tina-quant Cardiac high sensitivity CRP III is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K260026. The device is classified under product code NQD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tina-quant Cardiac high sensitivity CRP III?

Tina-quant Cardiac high sensitivity CRP III is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Roche Diagnostics. The 510(k) number is K260026.

When did Tina-quant Cardiac high sensitivity CRP III receive FDA 510(k) clearance?

Tina-quant Cardiac high sensitivity CRP III received FDA 510(k) clearance on 2026-04-02, under 510(k) number K260026.

Who is the listed applicant for Tina-quant Cardiac high sensitivity CRP III?

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 Tina-quant Cardiac high sensitivity CRP III?

The FDA product code for Tina-quant Cardiac high sensitivity CRP III is NQD.

列明Roche Diagnostics为申报人的其他记录

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