Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TISSUE OF ORIGIN TEST KIT FFPE

K-Number: K120489 · 2012-05-17

ApplicantPathwork Diagnostics, Inc.
Decision Date2012-05-17
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 Pathwork Diagnostics, Inc.. It received FDA 510(k) clearance on 2012-05-17 under 510(k) number K120489. 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 2012-05-17. The listed applicant is Pathwork Diagnostics, Inc.. The 510(k) number is K120489.

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 2012-05-17, under 510(k) number K120489.

Who is the listed applicant for TISSUE OF ORIGIN TEST KIT FFPE?

The FDA 510(k) record lists Pathwork Diagnostics, 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_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pathwork Diagnostics, Inc. as applicant

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.

K080896PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST

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.

K173839Tissue of Origin Test Kit-FFPECancer Genetics, 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.

↑