FDA 510(k)

ADVIA 化學酵素型血紅素 Ale (Alc_E) 測試

K 號：K200256 · 2021-07-02

決定日期2021-07-02

產品代碼PDJ

諮詢委員會CH

決定相當於

器材摘要

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K200256. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay?

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K200256.

When did ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay receive FDA 510(k) clearance?

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay received FDA 510(k) clearance on 2021-07-02, under 510(k) number K200256.

Who is the listed applicant for ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay?

FDA 510(k) 記錄將西门子醫療診斷公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay?

The FDA product code for ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay is PDJ.

其他以 Siemens Healthcare Diagnostics, Inc. 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。

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相關器械（代碼：PDJ）

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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