FDA 510(k)

D-10 糖化血紅蛋白A1c 計畫

K 號：K161687 · 2016-10-14

決定日期2016-10-14

產品代碼PDJ

諮詢委員會CH

決定相當於

器材摘要

D-10 Hemoglobin A1c Program is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K161687. 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 D-10 Hemoglobin A1c Program?

D-10 Hemoglobin A1c Program is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K161687.

When did D-10 Hemoglobin A1c Program receive FDA 510(k) clearance?

D-10 Hemoglobin A1c Program received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161687.

Who is the listed applicant for D-10 Hemoglobin A1c Program?

The FDA 510(k) record lists Bio-Rad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D-10 Hemoglobin A1c Program?

The FDA product code for D-10 Hemoglobin A1c Program is PDJ.

其他以 Bio-Rad Laboratories, 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。

K181661QXDx BCR-ABL %IS Kit，用於QXDx AutoDG ddPCR系統 K171664新生兒血色素變異體系統，配備GDM及HbReview軟體

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。

K252749Medconn 8K 糖化血紅蛋白檢測系統Shanghai Medconn Medical Technology Co., Ltd.K250073東和自動糖化血紅蛋白分析儀 HLC-723GR01Tosoh Bioscience, Inc.K242911Medconn 糖化血紅蛋白測試系統Shanghai Medconn Medical Technology Co., Ltd.K220999Hipro 糖化血紅素（HbA1c）測試系統Shijiazhuang Hipro Biotechnology Co., Ltd.K200904東和自動糖化血紅蛋白分析儀 HLC-723G8Tosoh Bioscience, Inc.K200256ADVIA 化學酵素型血紅素 Ale (Alc_E) 測試Siemens Healthcare Diagnostics, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。