FDA 510(k)

ADVIA 2120i, ADVIA 2120

K 號：K162977 · 2017-08-11

決定日期2017-08-11

產品代碼GKZ

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

ADVIA 2120i, ADVIA 2120 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2017-08-11 under 510(k) number K162977. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ADVIA 2120i, ADVIA 2120?

ADVIA 2120i, ADVIA 2120 is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K162977.

When did ADVIA 2120i, ADVIA 2120 receive FDA 510(k) clearance?

ADVIA 2120i, ADVIA 2120 received FDA 510(k) clearance on 2017-08-11, under 510(k) number K162977.

Who is the listed applicant for ADVIA 2120i, ADVIA 2120?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA 2120i, ADVIA 2120?

The FDA product code for ADVIA 2120i, ADVIA 2120 is GKZ.

其他以 Siemens Healthcare Diagnostics 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。

K243570維度LOCI 促甲状腺激素Flex試劑卡（TSHL）；維度LOCI 游離甲状腺素Flex試劑卡（FT4L）K162298LOCI 全部維生素D總測試，LOCI VITD CAL K161954Atellica Solution, Atellica A-LYTE 集成多感知器 Na+/K+/CI-, Atellica CH 醋酸白蛋白試劑 (Alb_p), Atellica IM 促甲状腺激素 TSH, Atellica CH 青霉素 (Vanc)K162538ADVIA Centaur Insulin (IRI) 主曲線材質 (MCM), ADVIA Centaur (IRI) 校正器 K151964Xprecia Stride 閃凝系統，Xprecia 系統 PT 控制

相關器械（代碼：GKZ）

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。

K260781裕米森 H550HORIBA ABX SAS K253212XR系列（XR-10，XR-20）自動血液學分析儀Sysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249真血學檢測Truvian Sciences, Inc.K250943Sysmex XR系列（XR-10）自動血液學分析儀Sysmex America, Inc.K251371Sysmex XR系列（XR-20）自動血液學分析儀Sysmex America, 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。