FDA 510(k)

Access 全總βhCG (第5個IS)

K 號：K221990 · 2022-12-27

決定日期2022-12-27

產品代碼DHA

諮詢委員會CH

決定相當於

器材摘要

Access Total ßhCG (5th IS) 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 2022-12-27 under 510(k) number K221990. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Access Total ßhCG (5th IS)?

Access Total ßhCG (5th IS) is a medical device that received FDA 510(k) clearance on 2022-12-27. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K221990.

When did Access Total ßhCG (5th IS) receive FDA 510(k) clearance?

Access Total ßhCG (5th IS) received FDA 510(k) clearance on 2022-12-27, under 510(k) number K221990.

Who is the listed applicant for Access Total ßhCG (5th IS)?

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 Total ßhCG (5th IS)?

The FDA product code for Access Total ßhCG (5th IS) is DHA.

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：DHA）

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。

K233581VITROS 免疫診斷產品全 β-hCG II 製劑包Ortho Clinical Diagnostics K223690iFlash-HCG；化學發光免疫分析儀（型號：iFlash 3000-C）Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i 全量 β-hCG 試劑套件，GLP系統追蹤Abbott Laboratories K230790Alinity i 全量 β-hCG 試劑套件，Alinity c 葡萄糖試劑套件，Alinity c ICT 樣本稀釋劑，Alinity ci-seriesAbbott Laboratories K212221迪亞茲美DZ-Lite iFlash全總beta-hCG測試，迪亞茲美DZ-Lite iFlash 1800化學發光免疫分析儀Diazyme Laboratories, Inc.K203227Elecsys HCG STATRoche Diagnostics

官方來源

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