FDA 510(k)

Elecsys AFP

K号: K220176 · 2022-09-15

决定日期2022-09-15

产品代码LOJ

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决定实质等同

器械摘要

Elecsys AFP is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2022-09-15 under 510(k) number K220176. The device is classified under product code LOJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elecsys AFP?

Elecsys AFP is a medical device that received FDA 510(k) clearance on 2022-09-15. The listed applicant is Roche Diagnostics. The 510(k) number is K220176.

When did Elecsys AFP receive FDA 510(k) clearance?

Elecsys AFP received FDA 510(k) clearance on 2022-09-15, under 510(k) number K220176.

Who is the listed applicant for Elecsys AFP?

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 AFP?

The FDA product code for Elecsys AFP is LOJ.

列明Roche Diagnostics为申报人的其他记录

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