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FDA 510(k)

Tissue of Origin Test Kit-FFPE

K-Number: K173839 · 2018-03-15

ApplicantCancer Genetics, Inc.
Decision Date2018-03-15
Product CodeOIW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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