FDA 510(k)

Access hsTnI

K 號：K242870 · 2025-06-16

決定日期2025-06-16

產品代碼MMI

諮詢委員會CH

決定相當於

器材摘要

Access hsTnI is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2025-06-16 under 510(k) number K242870. 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 Access hsTnI?

Access hsTnI is a medical device that received FDA 510(k) clearance on 2025-06-16. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K242870.

When did Access hsTnI receive FDA 510(k) clearance?

Access hsTnI received FDA 510(k) clearance on 2025-06-16, under 510(k) number K242870.

Who is the listed applicant for Access hsTnI?

FDA 510(k) 記錄將 Beckman Coulter, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Access hsTnI?

The FDA product code for Access hsTnI is MMI.

其他以 Beckman Coulter, 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.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.K231974PATHFAST®hs-cTnI-IIPhc Corporation

官方來源

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