FDA 510(k)

ADVIA Centaur CMV IgG 和 ADVIA Centaur CMV IgG 質量控制

K 號：K181213 · 2018-07-30

決定日期2018-07-30

產品代碼LFZ

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control 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 2018-07-30 under 510(k) number K181213. The device is classified under product code LFZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control?

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control is a medical device that received FDA 510(k) clearance on 2018-07-30. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K181213.

When did ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control receive FDA 510(k) clearance?

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control received FDA 510(k) clearance on 2018-07-30, under 510(k) number K181213.

Who is the listed applicant for ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control?

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 CMV IgG and ADVIA Centaur CMV IgG Quality Control?

The FDA product code for ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control is LFZ.

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。

K253528Atellica IM CA 19-9 II K261364Atellica CH 阿斯匹林 2 (ACTM)K251998Atellica CH 碘化物總膽紅素 (D_TBil)K251543Atellica® IM TSH3-Ultra II (TSH3ULII)K251630Atellica IM 全部前列腺特异性抗原 II (tPSAII)K250816ADVIA Centaur 抗甲状腺球蛋白II (aTgII)

查看所有 64 項裝置 →

相關器械（代碼：LFZ）

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。

K220949Architect CMV IgGAbbott Laboratories K220911Elecsys CMV IgGRoche Diagnostics K163569Elecsys CMV IgMRoche Diagnostics K162969LIAISON® CMV IgG 及 LIAISON® CMV IgG 血清控制組DiaSorin, Inc.

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。