FDA 510(k)

CAPI 3 Hb A1c, 多系統 Hb A1c 頸動控制 (2)

K 號：K162281 · 2017-02-17

申請人Sebia

決定日期2017-02-17

產品代碼LCP

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

CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2017-02-17 under 510(k) number K162281. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)?

CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) is a medical device that received FDA 510(k) clearance on 2017-02-17. The listed applicant is Sebia. The 510(k) number is K162281.

When did CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) receive FDA 510(k) clearance?

CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) received FDA 510(k) clearance on 2017-02-17, under 510(k) number K162281.

Who is the listed applicant for CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)?

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, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)?

The FDA product code for CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) is LCP.

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

查看所有 12 項裝置 →

相關器械（代碼：LCP）

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。

K221326諾瓦阿萊格羅HbA1c檢測，諾瓦阿萊格羅分析儀Nova Biomedical Corporation K231465Q-Pad測試系統Qurasense K214117Afinion™ HbA1c, Afinion™ 2 和 Alere Afinion™ AS100 分析儀Abbott Diagnostics Technologies AS K192987Aina HbA1c 监测系统 2Jana Care, Inc.K192369PixoTest POCT 系統 - PixoTest POCT 分析儀及 PixoTest A1c 檢測套件Ixensor Co, Ltd.K183230OneDraw A1C測試系統Drawbridge Health, Inc.

官方來源

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