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FDA 510(k)

URiSCAN 10ACR 尿试纸，用于 URiSCAN Optima 尿分析仪

K号: K182038 · 2018-12-10

申请人Yd Diagnostics Corporation
决定日期2018-12-10
产品代码JFY
咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Yd Diagnostics Corporation. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K182038. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer?

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Yd Diagnostics Corporation. The 510(k) number is K182038.

When did URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer receive FDA 510(k) clearance?

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer received FDA 510(k) clearance on 2018-12-10, under 510(k) number K182038.

Who is the listed applicant for URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer?

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

What is the FDA product code for URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer?

The FDA product code for URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer is JFY.

相关临床试验

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。

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相关器械（代码：JFY）

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。

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