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FDA 510(k)

MAGLUMI 2000 25-OH 腫島鹼

K 號：K191499 · 2019-08-01

申請人Shenzhen New Industries Biomedical Engineering Co., Ltd.
決定日期2019-08-01
產品代碼MRG
諮詢委員會CH
決定相當於

器材摘要

MAGLUMI 2000 25-OH Vitamin D is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. It received FDA 510(k) clearance on 2019-08-01 under 510(k) number K191499. 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 MAGLUMI 2000 25-OH Vitamin D?

MAGLUMI 2000 25-OH Vitamin D is a medical device that received FDA 510(k) clearance on 2019-08-01. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K191499.

When did MAGLUMI 2000 25-OH Vitamin D receive FDA 510(k) clearance?

MAGLUMI 2000 25-OH Vitamin D received FDA 510(k) clearance on 2019-08-01, under 510(k) number K191499.

Who is the listed applicant for MAGLUMI 2000 25-OH Vitamin D?

The FDA 510(k) record lists Shenzhen New Industries Biomedical Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGLUMI 2000 25-OH Vitamin D?

The FDA product code for MAGLUMI 2000 25-OH Vitamin D is MRG.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Shenzhen New Industries Biomedical Engineering Co., 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。

K232587MAGLUMI 25-OH 膠質D，MAGLUMI X3 全自動化化學發光免疫分析儀K192547MAGLUMI 2000 HCG/β-HCGK182423MAGLUMI 2000 FT4K162698MAGLUMI 2000 TSH, MAGLUMI 2000 適用化分析儀

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 DiagnosticsK200509ADVIA Centaur 全部維生素D (VitD)Siemens Healthcare Diagnostics, Inc.K180577BioPlex 2200 25-OH 腫生素D 套件Bio-Rad Laboratories

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