FDA 510(k)

HemosIL 遺傳性血友病因子抗原

K 號：K200033 · 2020-08-19

決定日期2020-08-19

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

HemosIL von Willebrand Factor Antigen is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K200033. 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 HemosIL von Willebrand Factor Antigen?

HemosIL von Willebrand Factor Antigen is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K200033.

When did HemosIL von Willebrand Factor Antigen receive FDA 510(k) clearance?

HemosIL von Willebrand Factor Antigen received FDA 510(k) clearance on 2020-08-19, under 510(k) number K200033.

Who is the listed applicant for HemosIL von Willebrand Factor Antigen?

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

What is the FDA product code for HemosIL von Willebrand Factor Antigen?

The FDA product code for HemosIL von Willebrand Factor Antigen is GGP.

其他以 Instrumentation Laboratory CO 為申請人之記錄

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。

K221359ACL TOP 970 CL, HemosIL CL 抗心磷脂IgM, HemosIL CL 抗ß2 糖蛋白-I IgM K223187HemosIL 液體抗-Xa K223090GEM預警者化學狀態監測系統 K223402HemosIL 遺傳性血友病因子抗原 K213464HemosIL 液體抗-Xa K213426HemosIL ReadiPlasTin

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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 K193204冷凍檢查顏色因子VIIIPrecision Biologic

官方來源

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