FDA 510(k)

HemosIL 適色因子IX

K 號：K230852 · 2023-12-13

決定日期2023-12-13

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 Chromogenic Factor IX is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory Company. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K230852. 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 Chromogenic Factor IX?

HemosIL Chromogenic Factor IX is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Instrumentation Laboratory Company. The 510(k) number is K230852.

When did HemosIL Chromogenic Factor IX receive FDA 510(k) clearance?

HemosIL Chromogenic Factor IX received FDA 510(k) clearance on 2023-12-13, under 510(k) number K230852.

Who is the listed applicant for HemosIL Chromogenic Factor IX?

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

What is the FDA product code for HemosIL Chromogenic Factor IX?

The FDA product code for HemosIL Chromogenic Factor IX is GGP.

其他以 Instrumentation Laboratory Company 為申請人之記錄

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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。

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官方來源

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