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FDA 510(k)

ARCHITECT STAT高灵敏度肌钙蛋白-I

K 號：K191595 · 2019-09-13

申請人Abbott Laboratories Diagnostics Division
決定日期2019-09-13
產品代碼MMI
諮詢委員會CH
決定相當於

器材摘要

ARCHITECT 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 2019-09-13 under 510(k) number K191595. 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 ARCHITECT STAT High Sensitivity Troponin-I?

ARCHITECT STAT High Sensitivity Troponin-I is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Abbott Laboratories Diagnostics Division. The 510(k) number is K191595.

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

ARCHITECT STAT High Sensitivity Troponin-I received FDA 510(k) clearance on 2019-09-13, under 510(k) number K191595.

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

The FDA product code for ARCHITECT 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K230994Alinity i 高敏度 Troponin-IK202525Alinity i 高敏度 Troponin-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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