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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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related Devices (Code: OIW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120489TISSUE OF ORIGIN TEST KIT FFPEPathwork Diagnostics, Inc.K092967PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPEPathwork DiagnosticsK080896PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TESTPathwork Diagnostics, Inc.

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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