FDA 510(k)

Atellica® IM 高敏度 Troponin I (TnIH)

K 號：K241165 · 2024-07-25

決定日期2024-07-25

產品代碼MMI

諮詢委員會CH

決定相當於

器材摘要

Atellica® IM High-Sensitivity Troponin I (TnIH) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-07-25 under 510(k) number K241165. 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 Atellica® IM High-Sensitivity Troponin I (TnIH)?

Atellica® IM High-Sensitivity Troponin I (TnIH) is a medical device that received FDA 510(k) clearance on 2024-07-25. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K241165.

When did Atellica® IM High-Sensitivity Troponin I (TnIH) receive FDA 510(k) clearance?

Atellica® IM High-Sensitivity Troponin I (TnIH) received FDA 510(k) clearance on 2024-07-25, under 510(k) number K241165.

Who is the listed applicant for Atellica® IM High-Sensitivity Troponin I (TnIH)?

FDA 510(k) 記錄將西门子醫療診斷公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Atellica® IM High-Sensitivity Troponin I (TnIH)?

The FDA product code for Atellica® IM High-Sensitivity Troponin I (TnIH) is MMI.

其他以 Siemens Healthcare Diagnostics, 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：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.K231974PATHFAST®hs-cTnI-IIPhc Corporation

官方來源

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