FDA 510(k)

Access 25(OH)維生素D總量檢測儀

K 號：K223503 · 2023-01-19

決定日期2023-01-19

產品代碼MRG

諮詢委員會CH

決定相當於

器材摘要

Access 25(OH) Vitamin D Total 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 2023-01-19 under 510(k) number K223503. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Access 25(OH) Vitamin D Total?

Access 25(OH) Vitamin D Total is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K223503.

When did Access 25(OH) Vitamin D Total receive FDA 510(k) clearance?

Access 25(OH) Vitamin D Total received FDA 510(k) clearance on 2023-01-19, under 510(k) number K223503.

Who is the listed applicant for Access 25(OH) Vitamin D Total?

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 25(OH) Vitamin D Total?

The FDA product code for Access 25(OH) Vitamin D Total is MRG.

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

查看所有 73 項裝置 →

相關器械（代碼：MRG）

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。

K232587MAGLUMI 25-OH 膠質D，MAGLUMI X3 全自動化化學發光免疫分析儀Shenzhen New Industries Biomedical Engineering Co., Ltd.K221817ALFIS 维生素D，ALFIS-3 分析儀Immunostics Inc.,K210901Elecsys 全部維生素D IIIRoche Diagnostics K200509ADVIA Centaur 全部維生素D (VitD)Siemens Healthcare Diagnostics, Inc.K191499MAGLUMI 2000 25-OH 腫島鹼Shenzhen New Industries Biomedical Engineering Co., Ltd.K180577BioPlex 2200 25-OH 腫生素D 套件Bio-Rad Laboratories

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。