The following data is part of a premarket notification filed by Pathwork Diagnostics, Inc. with the FDA for Pathwork Diagnostics Tissue Of Origin Test.
| Device ID | K080896 |
| 510k Number | K080896 |
| Device Name: | PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST |
| Classification | Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types |
| Applicant | PATHWORK DIAGNOSTICS, INC. 1196 BORREGAS AVE. SUITE 200 Sunnyvale, CA 94089 |
| Contact | Erika B Ammirati |
| Correspondent | Erika B Ammirati PATHWORK DIAGNOSTICS, INC. 1196 BORREGAS AVE. SUITE 200 Sunnyvale, CA 94089 |
| Product Code | OIW |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-07-30 |
| Summary: | summary |