Device Classification Name |
Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types
|
510(k) Number |
K173839 |
Device Name |
Tissue of Origin Test Kit-FFPE |
Applicant |
Cancer Genetics, Inc. |
1640 Marengo Street |
6th Floor |
Los Angeles,
CA
90033
|
|
Applicant Contact |
Janet Graff |
Correspondent |
Cancer Genetics, Inc. |
133 Southcenter Court |
Morrisville,
NC
27560
|
|
Correspondent Contact |
Victoria Kusel |
Regulation Number | 862.3100
|
Classification Product Code |
|
Date Received | 12/18/2017 |
Decision Date | 03/15/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|