The following data is part of a premarket notification filed by Cancer Genetics, Inc. with the FDA for Tissue Of Origin Test Kit-ffpe.
| Device ID | K173839 |
| 510k Number | K173839 |
| Device Name: | Tissue Of Origin Test Kit-FFPE |
| Classification | Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types |
| Applicant | Cancer Genetics, Inc. 1640 Marengo Street 6th Floor Los Angeles, CA 90033 |
| Contact | Janet Graff |
| Correspondent | Victoria Kusel Cancer Genetics, Inc. 133 Southcenter Court Morrisville, NC 27560 |
| Product Code | OIW |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-18 |
| Decision Date | 2018-03-15 |
| Summary: | summary |