FDA 510(k)

Sysmex UD-10，全自动尿液颗粒数字成像设备

K号: K182062 · 2018-10-30

决定日期2018-10-30

产品代码JOY

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决定实质等同

器械摘要

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex America, Inc.. It received FDA 510(k) clearance on 2018-10-30 under 510(k) number K182062. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device?

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device is a medical device that received FDA 510(k) clearance on 2018-10-30. The listed applicant is Sysmex America, Inc.. The 510(k) number is K182062.

When did Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device receive FDA 510(k) clearance?

Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device received FDA 510(k) clearance on 2018-10-30, under 510(k) number K182062.

Who is the listed applicant for Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device?

The FDA 510(k) record lists Sysmex America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device?

The FDA product code for Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device is JOY.

列明Sysmex America, 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。

K253212XR系列（XR-10，XR-20）自动血液分析仪 K250943Sysmex XR-Series (XR-10) 自动血液分析仪 K251371Sysmex XR-Series (XR-20) 自动血液分析仪 K250965自动血凝分析仪CN系列（CN-6000）K230887Sysmex XQ-Series (XQ-320) 自动血液分析仪 K210346Sysmex XW-100 自动血液分析仪

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官方来源

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