FDA 510(k)

Tissue of Origin Test Kit-FFPE

K-Number: K173839 · 2018-03-15

Decision Date2018-03-15

Product CodeOIW

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

Tissue of Origin Test Kit-FFPE is a medical device manufactured by Cancer Genetics, Inc.. It received FDA 510(k) clearance on 2018-03-15 under approval number K173839. The device is classified under product code OIW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Cancer Genetics, Inc.. The 510(k) number is K173839.

When was Tissue of Origin Test Kit-FFPE approved by the FDA?

Tissue of Origin Test Kit-FFPE received FDA 510(k) clearance on 2018-03-15, under approval number K173839.

What company makes Tissue of Origin Test Kit-FFPE?

Tissue of Origin Test Kit-FFPE is manufactured by Cancer Genetics, Inc..

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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Official Source

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