FDA 510(k)

Access 腺皮質醇

K 號：K223038 · 2023-02-08

決定日期2023-02-08

產品代碼CGR

諮詢委員會CH

決定相當於

器材摘要

Access Cortisol 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 2023-02-08 under 510(k) number K223038. 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?

Access Cortisol is a medical device that received FDA 510(k) clearance on 2023-02-08. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K223038.

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

Access Cortisol received FDA 510(k) clearance on 2023-02-08, under 510(k) number K223038.

Who is the listed applicant for Access Cortisol?

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?

The FDA product code for Access Cortisol 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。

K262109AccessNT-proBNP K252169Access BNP II K254059Access anti-HBc IgM K253687Access anti-HBc Total K251995Access anti-HAV IgM K250588Access德國麻疹IgG

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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。

K242190Access 腺皮質醇；DxC 500i臨床分析儀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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