FDA 510(k)

vWF抗體

K 號：K220728 · 2023-06-02

申請人Siemens Healthcare Diagnostics Products GmbH

決定日期2023-06-02

產品代碼GGP

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

vWF Ag is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K220728. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the vWF Ag?

vWF Ag is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K220728.

When did vWF Ag receive FDA 510(k) clearance?

vWF Ag received FDA 510(k) clearance on 2023-06-02, under 510(k) number K220728.

Who is the listed applicant for vWF Ag?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for vWF Ag?

The FDA product code for vWF Ag is GGP.

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