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FDA 510(k)

Alinity i 高敏度 Troponin-I

K 號：K230994 · 2023-05-04

申請人Abbott Laboratories Diagnostics Division
決定日期2023-05-04
產品代碼MMI
諮詢委員會CH
決定相當於

器材摘要

Alinity i STAT High Sensitivity Troponin-I is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories Diagnostics Division. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K230994. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alinity i STAT High Sensitivity Troponin-I?

Alinity i STAT High Sensitivity Troponin-I is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Abbott Laboratories Diagnostics Division. The 510(k) number is K230994.

When did Alinity i STAT High Sensitivity Troponin-I receive FDA 510(k) clearance?

Alinity i STAT High Sensitivity Troponin-I received FDA 510(k) clearance on 2023-05-04, under 510(k) number K230994.

Who is the listed applicant for Alinity i STAT High Sensitivity Troponin-I?

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

What is the FDA product code for Alinity i STAT High Sensitivity Troponin-I?

The FDA product code for Alinity i STAT High Sensitivity Troponin-I is MMI.

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 Laboratories Diagnostics Division 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。

K240468鹼性磷酸鹽K202525Alinity i 高敏度 Troponin-IK191595ARCHITECT STAT高灵敏度肌钙蛋白-I

相關器械（代碼：MMI）

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。

K253051i-STAT hs-TnI 車籠，配用 i-STAT Alinity 系統Abbott Point of Care, Inc.K252393VITROS 免疫診斷產品 hs Troponin I 製劑包Ortho-Clinical Diagnostics, Inc.K243483Access hsTnIBeckman Coulter, Inc.K242870Access hsTnIBeckman Coulter, Inc.K240984i-STAT hs-TnI 車籠，配用 i-STAT 1 系統Abbott Point of Care, Inc.K241165Atellica® IM 高敏度 Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc.

官方來源

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