FDA 510(k)

Access葉酸測試

K 號：K223590 · 2023-08-23

決定日期2023-08-23

產品代碼CGN

諮詢委員會CH

決定相當於

器材摘要

Access Folate Assay 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 2023-08-23 under 510(k) number K223590. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Access Folate Assay?

Access Folate Assay is a medical device that received FDA 510(k) clearance on 2023-08-23. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K223590.

When did Access Folate Assay receive FDA 510(k) clearance?

Access Folate Assay received FDA 510(k) clearance on 2023-08-23, under 510(k) number K223590.

Who is the listed applicant for Access Folate Assay?

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 Folate Assay?

The FDA product code for Access Folate Assay is CGN.

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：CGN）

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。

K233060Elecsys Folate IIIRoche Diagnostics K192586LIAISON® 叶酸DiaSorin, Inc.K172201Atellica IM 腫瘤標記物葉酸測試Siemens Healthcare Diagnostics, Inc.K161646迪亞茲美葉酸測試，迪亞茲美葉酸校準組合，迪亞茲美葉酸控制組合Diazyme Laboratories

官方來源

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