FDA 510(k)

科博斯u 701显微镜分析仪

K号: K200811 · 2020-11-06

决定日期2020-11-06

产品代码LKM

咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

cobas u 701 microscopy analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2020-11-06 under 510(k) number K200811. 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 cobas u 701 microscopy analyzer?

cobas u 701 microscopy analyzer is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Roche Diagnostics. The 510(k) number is K200811.

When did cobas u 701 microscopy analyzer receive FDA 510(k) clearance?

cobas u 701 microscopy analyzer received FDA 510(k) clearance on 2020-11-06, under 510(k) number K200811.

Who is the listed applicant for cobas u 701 microscopy analyzer?

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 701 microscopy analyzer?

The FDA product code for cobas u 701 microscopy analyzer is LKM.

列明Roche Diagnostics为申报人的其他记录

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