Tissue of Origin Test Kit-FFPE— 510(k) K173839

Name: FDA 510(k) clearance K173839
Creator: U.S. Food and Drug Administration
Published: 2018-03-15

Substantially Equivalent

Cancer Genetics, Inc.

FDA 510(k) clearance K173839 for Tissue of Origin Test Kit-FFPE, Substantially Equivalent on 2018-03-15. Applicant: Cancer Genetics, Inc.. Device class: 2.

Clearance details

Applicant: Cancer Genetics, Inc.
Product code: Code OIW
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2017-12-18
Decision date: 2018-03-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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