FDA 510(k)

ROMA使用Elecsys检测的ROMA计算工具

K号: K153607 · 2016-06-15

决定日期2016-06-15

产品代码ONX

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决定实质等同

器械摘要

ROMA Calculation Tool Using Elecsys Assays is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2016-06-15 under 510(k) number K153607. The device is classified under product code ONX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ROMA Calculation Tool Using Elecsys Assays?

ROMA Calculation Tool Using Elecsys Assays is a medical device that received FDA 510(k) clearance on 2016-06-15. The listed applicant is Roche Diagnostics. The 510(k) number is K153607.

When did ROMA Calculation Tool Using Elecsys Assays receive FDA 510(k) clearance?

ROMA Calculation Tool Using Elecsys Assays received FDA 510(k) clearance on 2016-06-15, under 510(k) number K153607.

Who is the listed applicant for ROMA Calculation Tool Using Elecsys Assays?

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 ROMA Calculation Tool Using Elecsys Assays?

The FDA product code for ROMA Calculation Tool Using Elecsys Assays is ONX.

列明Roche Diagnostics为申报人的其他记录

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K261686Elecsys 磷酸-Tau（217P）血浆 K252323科博斯脉搏血糖监测系统 K252280Elecsys 抗-SARS-CoV-2 S K260049Elecsys Anti-HBc IgM K260048Elecsys Anti-HAV IgM K260046Elecsys Anti-HBc II

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