ADVIA Centaur 全部維生素D (VitD)
K 號：K200509 · 2020-05-29
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器材摘要
ADVIA Centaur Vitamin D Total (VitD) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K200509. 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 ADVIA Centaur Vitamin D Total (VitD)?
ADVIA Centaur Vitamin D Total (VitD) is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K200509.
When did ADVIA Centaur Vitamin D Total (VitD) receive FDA 510(k) clearance?
ADVIA Centaur Vitamin D Total (VitD) received FDA 510(k) clearance on 2020-05-29, under 510(k) number K200509.
Who is the listed applicant for ADVIA Centaur Vitamin D Total (VitD)?
FDA 510(k) 記錄將西门子醫療診斷公司列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for ADVIA Centaur Vitamin D Total (VitD)?
The FDA product code for ADVIA Centaur Vitamin D Total (VitD) is MRG.
相關臨床試驗
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其他以 Siemens Healthcare Diagnostics, 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。
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.,K223503Access 25(OH)維生素D總量檢測儀Beckman Coulter, Inc.K210901Elecsys 全部維生素D IIIRoche DiagnosticsK191499MAGLUMI 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。
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