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FDA 510(k)

i-STAT CG8+ 車籠，配用 i-STAT 1 系統

K 號：K223710 · 2023-07-28

申請人Abbott Point of Care, Inc.
決定日期2023-07-28
產品代碼CGA
諮詢委員會CH
決定相當於

器材摘要

i-STAT CG8+ cartridge with the i-STAT 1 System 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 2023-07-28 under 510(k) number K223710. 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 CG8+ cartridge with the i-STAT 1 System?

i-STAT CG8+ cartridge with the i-STAT 1 System is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K223710.

When did i-STAT CG8+ cartridge with the i-STAT 1 System receive FDA 510(k) clearance?

i-STAT CG8+ cartridge with the i-STAT 1 System received FDA 510(k) clearance on 2023-07-28, under 510(k) number K223710.

Who is the listed applicant for i-STAT CG8+ cartridge with the i-STAT 1 System?

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 CG8+ cartridge with the i-STAT 1 System?

The FDA product code for i-STAT CG8+ cartridge with the i-STAT 1 System 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。

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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.K223090GEM預警者化學狀態監測系統Instrumentation Laboratory CO

官方來源

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