FDA 510(k)

冷凍檢查第八因子缺乏之VWF血漿

K 號：K222831 · 2023-09-13

決定日期2023-09-13

產品代碼GJT

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

CRYOcheck Factor VIII Deficient Plasma with VWF is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biologic, Inc.. It received FDA 510(k) clearance on 2023-09-13 under 510(k) number K222831. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CRYOcheck Factor VIII Deficient Plasma with VWF?

CRYOcheck Factor VIII Deficient Plasma with VWF is a medical device that received FDA 510(k) clearance on 2023-09-13. The listed applicant is Precision Biologic, Inc.. The 510(k) number is K222831.

When did CRYOcheck Factor VIII Deficient Plasma with VWF receive FDA 510(k) clearance?

CRYOcheck Factor VIII Deficient Plasma with VWF received FDA 510(k) clearance on 2023-09-13, under 510(k) number K222831.

Who is the listed applicant for CRYOcheck Factor VIII Deficient Plasma with VWF?

The FDA 510(k) record lists Precision Biologic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYOcheck Factor VIII Deficient Plasma with VWF?

The FDA product code for CRYOcheck Factor VIII Deficient Plasma with VWF is GJT.

其他以 Precision Biologic, Inc. 為申請人之記錄

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相關器械（代碼：GJT）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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