FDA 510(k)

iQ200 系統，iChemVELOCITY 自动化尿液化學系統

K 號：K210127 · 2021-07-02

決定日期2021-07-02

產品代碼LKM

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

iQ200 System, iChemVELOCITY Automated Urine Chemistry System is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K210127. The device is classified under product code LKM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iQ200 System, iChemVELOCITY Automated Urine Chemistry System?

iQ200 System, iChemVELOCITY Automated Urine Chemistry System is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K210127.

When did iQ200 System, iChemVELOCITY Automated Urine Chemistry System receive FDA 510(k) clearance?

iQ200 System, iChemVELOCITY Automated Urine Chemistry System received FDA 510(k) clearance on 2021-07-02, under 510(k) number K210127.

Who is the listed applicant for iQ200 System, iChemVELOCITY Automated Urine Chemistry System?

FDA 510(k) 記錄將 Beckman Coulter, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for iQ200 System, iChemVELOCITY Automated Urine Chemistry System?

The FDA product code for iQ200 System, iChemVELOCITY Automated Urine Chemistry System is LKM.

其他以 Beckman Coulter, 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。

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相關器械（代碼：LKM）

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。

K252580iQ200 系列Beckman Coulter, Inc.K232416AUTION EYE AI-4510 尿沉渣分析系統Arkray, Inc.K200811cobas u 701顯微鏡分析儀Roche Diagnostics K171883希森美康 UF-5000 全自動尿沉渣分析儀Sysmex America, Inc.

官方來源

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