FDA 510(k)

Elecsys 抗-SARS-CoV-2

K号: K253839 · 2025-12-17

决定日期2025-12-17

产品代码QVP

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决定实质等同

器械摘要

Elecsys Anti-SARS-CoV-2 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2025-12-17 under 510(k) number K253839. The device is classified under product code QVP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elecsys Anti-SARS-CoV-2?

Elecsys Anti-SARS-CoV-2 is a medical device that received FDA 510(k) clearance on 2025-12-17. The listed applicant is Roche Diagnostics. The 510(k) number is K253839.

When did Elecsys Anti-SARS-CoV-2 receive FDA 510(k) clearance?

Elecsys Anti-SARS-CoV-2 received FDA 510(k) clearance on 2025-12-17, under 510(k) number K253839.

Who is the listed applicant for Elecsys Anti-SARS-CoV-2?

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 Anti-SARS-CoV-2?

The FDA product code for Elecsys Anti-SARS-CoV-2 is QVP.

列明Roche Diagnostics为申报人的其他记录

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