FDA 510(k)

DUS R-50S（尿液化学系统）

K号: K171521 · 2018-02-16

决定日期2018-02-16

产品代码JIL

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决定实质等同

器械摘要

DUS R-50S (Urine Chemistry system) is the device name listed in this FDA 510(k) record. The listed applicant is DFI Co., Ltd.. It received FDA 510(k) clearance on 2018-02-16 under 510(k) number K171521. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DUS R-50S (Urine Chemistry system)?

DUS R-50S (Urine Chemistry system) is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is DFI Co., Ltd.. The 510(k) number is K171521.

When did DUS R-50S (Urine Chemistry system) receive FDA 510(k) clearance?

DUS R-50S (Urine Chemistry system) received FDA 510(k) clearance on 2018-02-16, under 510(k) number K171521.

Who is the listed applicant for DUS R-50S (Urine Chemistry system)?

The FDA 510(k) record lists DFI Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUS R-50S (Urine Chemistry system)?

The FDA product code for DUS R-50S (Urine Chemistry system) is JIL.

列明DFI Co., Ltd.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。

K181024DUS 2GP 试剂条，DUS 5 试剂条，DUS 10 试剂条

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