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FDA 510(k)

ARCHITECT Active-B12 (全轉運型葉酸鹽)

K 號：K233541 · 2024-07-31

申請人Axis-Shield Diagnostics, Ltd.
決定日期2024-07-31
產品代碼CDD
諮詢委員會CH
決定相當於

器材摘要

ARCHITECT Active-B12 (Holotranscobalamin) is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K233541. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARCHITECT Active-B12 (Holotranscobalamin)?

ARCHITECT Active-B12 (Holotranscobalamin) is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is Axis-Shield Diagnostics, Ltd.. The 510(k) number is K233541.

When did ARCHITECT Active-B12 (Holotranscobalamin) receive FDA 510(k) clearance?

ARCHITECT Active-B12 (Holotranscobalamin) received FDA 510(k) clearance on 2024-07-31, under 510(k) number K233541.

Who is the listed applicant for ARCHITECT Active-B12 (Holotranscobalamin)?

The FDA 510(k) record lists Axis-Shield Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARCHITECT Active-B12 (Holotranscobalamin)?

The FDA product code for ARCHITECT Active-B12 (Holotranscobalamin) is CDD.

相關臨床試驗

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其他以 Axis-Shield Diagnostics, Ltd. 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。

K253539Alere NT-proBNP for Alinity iK241176Alere NT-proBNP for Alinity i試劑盒K172133ADVIA Centaur Active-B12 (全反式轉運型維生素B12) (AB12) 測試

相關器械（代碼：CDD）

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。

K223289Access 鎘B12Beckman Coulter, Inc.K190298DxA 5000, DxI 800 免疫測定系統，Access 鐵蛋白測試，Access 叶酸測試，Access 促甲状腺激素（第3代國際標準品），Access B12維生素Beckman Coulter Biomedical GmbHK192064聯盟維生素B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (全反式轉運型維生素B12) (AB12) 測試Axis-Shield Diagnostics, Ltd.K161721迪亞茲美維生素B12測試，迪亞茲美維生素B12校准器組，迪亞茲美維生素B12控制組Diazyme LaboratoriesK160757ADVIA Centaur Active-B12 (全反式轉運型維生素B12) (AB12) 測試, ADVIA Centaur Active-B12(AB12) 質量控制，以及 ADVIA Centaur Active-B12 (AB12) 主曲線材料 (MCM)Axis-Shield Diagnostics Limited

官方來源

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