FDA 510(k)

科博斯因子II和因子V检测

K号: K172913 · 2018-01-12

决定日期2018-01-12

产品代码NPR

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决定实质等同

器械摘要

cobas Factor II and Factor V Test is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K172913. The device is classified under product code NPR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the cobas Factor II and Factor V Test?

cobas Factor II and Factor V Test is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K172913.

When did cobas Factor II and Factor V Test receive FDA 510(k) clearance?

cobas Factor II and Factor V Test received FDA 510(k) clearance on 2018-01-12, under 510(k) number K172913.

Who is the listed applicant for cobas Factor II and Factor V Test?

FDA 510(k)记录中列出罗氏分子系统有限公司为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for cobas Factor II and Factor V Test?

The FDA product code for cobas Factor II and Factor V Test is NPR.

列明Roche Molecular Systems, 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。

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