组织来源检测试剂盒-FFPE
K号: K173839 · 2018-03-15
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决定日期2018-03-15
产品代码OIW
咨询委员会TX
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决定实质等同
器械摘要
Tissue of Origin Test Kit-FFPE is the device name listed in this FDA 510(k) record. The listed applicant is Cancer Genetics, Inc.. It received FDA 510(k) clearance on 2018-03-15 under 510(k) number K173839. The device is classified under product code OIW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Tissue of Origin Test Kit-FFPE?
Tissue of Origin Test Kit-FFPE is a medical device that received FDA 510(k) clearance on 2018-03-15. The listed applicant is Cancer Genetics, Inc.. The 510(k) number is K173839.
When did Tissue of Origin Test Kit-FFPE receive FDA 510(k) clearance?
Tissue of Origin Test Kit-FFPE received FDA 510(k) clearance on 2018-03-15, under 510(k) number K173839.
Who is the listed applicant for Tissue of Origin Test Kit-FFPE?
The FDA 510(k) record lists Cancer Genetics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tissue of Origin Test Kit-FFPE?
The FDA product code for Tissue of Origin Test Kit-FFPE is OIW.
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