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FDA 510(k)

i-STAT Alinity 系統搭配 i-STAT 钠濃度檢測

K 號：K153357 · 2016-07-08

申請人Abbott Point of Care, Inc.
決定日期2016-07-08
產品代碼JGS
諮詢委員會CH
決定相當於

器材摘要

i-STAT Alinity System with i-STAT Sodium 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 2016-07-08 under 510(k) number K153357. The device is classified under product code JGS. 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 Sodium test?

i-STAT Alinity System with i-STAT Sodium test is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K153357.

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

i-STAT Alinity System with i-STAT Sodium test received FDA 510(k) clearance on 2016-07-08, under 510(k) number K153357.

Who is the listed applicant for i-STAT Alinity System with i-STAT Sodium 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 Sodium test?

The FDA product code for i-STAT Alinity System with i-STAT Sodium test is JGS.

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。

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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：JGS）

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。

K252475ABL90 FLEX PLUS 系統Radiometer Medicals ApsK230275i-STAT CG8+ 車籠，配用 i-STAT 1 系統Abbott Point of Care, Inc.K222438A-LYTE® 集成多感知器（IMT Na K Cl）Siemens Healthcare Diagnostics, Inc.K220977ISE試劑，葡萄糖，CRP膠乳，DxC 500 AU臨床化學分析儀Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP系統追蹤Abbott LaboratoriesK200403統計配置文件Prime Plus分析系統Nova Biomedical Corporation

官方來源

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