PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE is an AI-enabled medical device from PATHWORK DIAGNOSTICS, listed by FDA (510(k), K092967) with a decision date of 2010-06-08. Review panel: Clinical Toxcicology.
| FDA submission number | K092967 |
|---|---|
| Pathway | 510(k) |
| Company | PATHWORK DIAGNOSTICS |
| Review panel (specialty) | Clinical Toxcicology |
| FDA decision date | 2010-06-08 |
| 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) | 256 |
| Applicant country | US |
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.