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FDA 510(k)

i-Stat Alinity 系統搭配 i-Stat 葡萄糖檢測

K 號：K163271 · 2017-04-10

申請人Abbott Point of Care, Inc.
決定日期2017-04-10
產品代碼CGA
諮詢委員會CH
決定相當於

器材摘要

i-Stat Alinity System with i-Stat Glucose test is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Point of Care, Inc.. It received FDA 510(k) clearance on 2017-04-10 under 510(k) number K163271. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the i-Stat Alinity System with i-Stat Glucose test?

i-Stat Alinity System with i-Stat Glucose test is a medical device that received FDA 510(k) clearance on 2017-04-10. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K163271.

When did i-Stat Alinity System with i-Stat Glucose test receive FDA 510(k) clearance?

i-Stat Alinity System with i-Stat Glucose test received FDA 510(k) clearance on 2017-04-10, under 510(k) number K163271.

Who is the listed applicant for i-Stat Alinity System with i-Stat Glucose test?

The FDA 510(k) record lists Abbott Point of Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i-Stat Alinity System with i-Stat Glucose test?

The FDA product code for i-Stat Alinity System with i-Stat Glucose test is CGA.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Abbott Point of Care, 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。

K261039i-STAT Crea濾芯與i-STAT 1系統K253051i-STAT hs-TnI 車籠，配用 i-STAT Alinity 系統K244014i-STAT CG4+ 車籠，配用 i-STAT 1 系統K240984i-STAT hs-TnI 車籠，配用 i-STAT 1 系統K230275i-STAT CG8+ 車籠，配用 i-STAT 1 系統K230285i-STAT CG8+ 車籠，配用 i-STAT 1 系統

查看所有 19 項裝置 →

相關器械（代碼：CGA）

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。

K252488ABL90 FLEX PLUS 系統Radiometer Medicals ApsK210933YSI 2900C 生化分析仪Ysi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX™ 系統Alere San Diego, Inc.K223755i-STAT G 車籠，配用 i-STAT 1 系統Abbott Point of Care, Inc.K223710i-STAT CG8+ 車籠，配用 i-STAT 1 系統Abbott Point of Care, Inc.

官方來源

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