The following data is part of a premarket notification filed by Pathwork Diagnostics with the FDA for Pathwork Tissue Of Origin Test Kit-ffpe (origin Test Kit-ffpe.
| Device ID | K092967 |
| 510k Number | K092967 |
| Device Name: | PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE |
| Classification | Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types |
| Applicant | PATHWORK DIAGNOSTICS 595 PENOBSCOT DRIVE Redwood City, CA 94063 |
| Contact | Anna Longwell |
| Correspondent | Anna Longwell PATHWORK DIAGNOSTICS 595 PENOBSCOT DRIVE Redwood City, CA 94063 |
| Product Code | OIW |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-25 |
| Decision Date | 2010-06-08 |
| Summary: | summary |