FDA 510(k)

IDS-iSYS 25VitDs, IDS-iSYS 25VitDs 控制組

K 號：K161831 · 2016-11-15

決定日期2016-11-15

產品代碼MRG

諮詢委員會CH

決定相當於

器材摘要

IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K161831. 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 IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set?

IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K161831.

When did IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set receive FDA 510(k) clearance?

IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set received FDA 510(k) clearance on 2016-11-15, under 510(k) number K161831.

Who is the listed applicant for IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set?

The FDA 510(k) record lists Immunodiagnostic Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set?

The FDA product code for IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set is MRG.

其他以 Immunodiagnostic Systems , 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。

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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 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.

官方來源

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