The following data is part of a premarket notification filed by Pathwork Diagnostics, Inc. with the FDA for Tissue Of Origin Test Kit Ffpe.
| Device ID | K120489 |
| 510k Number | K120489 |
| Device Name: | TISSUE OF ORIGIN TEST KIT FFPE |
| Classification | Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types |
| Applicant | PATHWORK DIAGNOSTICS, INC. 1900 EMBARCADERO ROAD Palo Alto, CA 94303 |
| Contact | Anna Longwell |
| Correspondent | Anna Longwell PATHWORK DIAGNOSTICS, INC. 1900 EMBARCADERO ROAD Palo Alto, CA 94303 |
| Product Code | OIW |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-17 |
| Decision Date | 2012-05-17 |
| Summary: | summary |