FDA 510(k)

冷凍檢查顏色因子VIII

K 號：K193204 · 2020-07-17

決定日期2020-07-17

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

Cryocheck Chromogenic Factor VIII is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biologic. It received FDA 510(k) clearance on 2020-07-17 under 510(k) number K193204. 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 Cryocheck Chromogenic Factor VIII?

Cryocheck Chromogenic Factor VIII is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Precision Biologic. The 510(k) number is K193204.

When did Cryocheck Chromogenic Factor VIII receive FDA 510(k) clearance?

Cryocheck Chromogenic Factor VIII received FDA 510(k) clearance on 2020-07-17, under 510(k) number K193204.

Who is the listed applicant for Cryocheck Chromogenic Factor VIII?

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

What is the FDA product code for Cryocheck Chromogenic Factor VIII?

The FDA product code for Cryocheck Chromogenic Factor VIII is GGP.

其他以 Precision Biologic 為申請人之記錄

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K193556冷凍檢查式LA

相關器械（代碼：GGP）

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。

K251440CRYOcheck 適合因子VIII 適合性檢測Precision Biologic, Inc.K230852HemosIL 適色因子IXInstrumentation Laboratory Company K220728vWF抗體Siemens Healthcare Diagnostics Products GmbH K214002CRYOcheck 銀色凝血因子IXPrecision Biologic, Inc.K223402HemosIL 遺傳性血友病因子抗原Instrumentation Laboratory CO K200033HemosIL 遺傳性血友病因子抗原Instrumentation Laboratory CO

官方來源

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