FDA 510(k)

Elecsys 睾酮 II

K号: K211685 · 2022-05-06

决定日期2022-05-06

产品代码CDZ

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决定实质等同

器械摘要

Elecsys Testosterone II is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K211685. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elecsys Testosterone II?

Elecsys Testosterone II is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Roche Diagnostics. The 510(k) number is K211685.

When did Elecsys Testosterone II receive FDA 510(k) clearance?

Elecsys Testosterone II received FDA 510(k) clearance on 2022-05-06, under 510(k) number K211685.

Who is the listed applicant for Elecsys Testosterone II?

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 Testosterone II?

The FDA product code for Elecsys Testosterone II is CDZ.

列明Roche Diagnostics为申报人的其他记录

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