FDA 510(k)

iQ200系统，iChemVELOCITY自动尿液化学分析系统

K号: K210127 · 2021-07-02

决定日期2021-07-02

产品代码LKM

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决定实质等同

器械摘要

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.

常见问题

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)记录中列出Beckman Coulter, Inc.为申请人。这本身并不能确立该设备制造商的身份。

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.

列明Beckman Coulter, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262109Access NT-proBNP K252169Access BNP II K254059Access 乙型肝炎核心抗体IgM K253687Access 乙型肝炎核心抗体总抗体 K251995Access 乙型肝炎核心抗体IgM K250588Access 风疹IgG

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官方来源

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