FDA 510(k)

cobas u 601 尿分析测试系统

K号: K183432 · 2019-05-07

决定日期2019-05-07

产品代码JIL

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

cobas u 601 urinalysis test system is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2019-05-07 under 510(k) number K183432. 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 cobas u 601 urinalysis test system?

cobas u 601 urinalysis test system is a medical device that received FDA 510(k) clearance on 2019-05-07. The listed applicant is Roche Diagnostics. The 510(k) number is K183432.

When did cobas u 601 urinalysis test system receive FDA 510(k) clearance?

cobas u 601 urinalysis test system received FDA 510(k) clearance on 2019-05-07, under 510(k) number K183432.

Who is the listed applicant for cobas u 601 urinalysis test system?

FDA 510(k)记录显示罗氏诊断公司为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for cobas u 601 urinalysis test system?

The FDA product code for cobas u 601 urinalysis test system is JIL.

列明Roche Diagnostics为申报人的其他记录

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