Tissue of Origin Test Kit-FFPE is an AI-enabled medical device from Cancer Genetics, Inc., listed by FDA (510(k), K173839) with a decision date of 2018-03-15. Review panel: Clinical Toxcicology.
| FDA submission number | K173839 |
|---|---|
| Pathway | 510(k) |
| Company | Cancer Genetics, Inc. |
| Review panel (specialty) | Clinical Toxcicology |
| FDA decision date | 2018-03-15 |
| Decision | Substantially Equivalent |
| Product code | OIW |
| Classification | Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types |
| Device class | 2 |
| Regulation number | 862.3100 |
| Review time (calendar days) | 87 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Clinical Toxcicology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.