FDA 510(k)

Access 腺皮質醇；DxC 500i臨床分析儀

K 號：K242190 · 2025-03-05

決定日期2025-03-05

產品代碼CGR

諮詢委員會CH

決定相當於

器材摘要

Access Cortisol; DxC 500i Clinical Analyzer 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 2025-03-05 under 510(k) number K242190. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Access Cortisol; DxC 500i Clinical Analyzer?

Access Cortisol; DxC 500i Clinical Analyzer is a medical device that received FDA 510(k) clearance on 2025-03-05. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K242190.

When did Access Cortisol; DxC 500i Clinical Analyzer receive FDA 510(k) clearance?

Access Cortisol; DxC 500i Clinical Analyzer received FDA 510(k) clearance on 2025-03-05, under 510(k) number K242190.

Who is the listed applicant for Access Cortisol; DxC 500i Clinical Analyzer?

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 Cortisol; DxC 500i Clinical Analyzer?

The FDA product code for Access Cortisol; DxC 500i Clinical Analyzer is CGR.

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：CGR）

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。

K223038Access 腺皮質醇Beckman Coulter, Inc.K202136IDS皮質醇Immunodiagnostic Systems , Ltd.K202826IMMULITE® 2000 皮質醇Siemens Healthcare Diagnostics Products, Ltd.K203270IMMULITE/IMMULITE® 1000 皮質醇Siemens Healthcare Diagnostics Products, Ltd.

官方來源

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