FDA 510(k)

CAPI 3 HbA1c

K 號：K171537 · 2017-09-12

申請人Sebia

決定日期2017-09-12

產品代碼PDJ

諮詢委員會CH

決定相當於

器材摘要

CAPI 3 Hb A1c is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2017-09-12 under 510(k) number K171537. 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 CAPI 3 Hb A1c?

CAPI 3 Hb A1c is a medical device that received FDA 510(k) clearance on 2017-09-12. The listed applicant is Sebia. The 510(k) number is K171537.

When did CAPI 3 Hb A1c receive FDA 510(k) clearance?

CAPI 3 Hb A1c received FDA 510(k) clearance on 2017-09-12, under 510(k) number K171537.

Who is the listed applicant for CAPI 3 Hb A1c?

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

What is the FDA product code for CAPI 3 Hb A1c?

The FDA product code for CAPI 3 Hb A1c is PDJ.

其他以 Sebia 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。

K232027CAPI 3 新生兒 Hb，毛細血管 3 DBS 裝置 K231601FLC Kappa、FLC Lambda、FLC 控制等級 1、FLC 控制等級 2 K210623FLC Kappa、FLC Lambda、FLC 控制等級 1、FLC 控制等級 2 K203184HYDRASHIFT 2/4 艾沙珠单抗 K192095CAPI 3 免疫分類，Capillarys 3 Tera K190851HYDRASHIFT 2/4 達雷木单抗

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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。

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

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