Device Classification Name |
Next Generation Sequencing Based Tumor Profiling Test
|
510(k) Number |
K190661 |
Device Name |
Omics Core |
Applicant |
NantHealth, Inc. |
9920 Jefferson Blvd |
Culver City,
CA
90232
|
|
Applicant Contact |
Aleece Nolasco |
Correspondent |
NantHealth, Inc. |
9920 Jefferson Blvd |
Culver City,
CA
90232
|
|
Correspondent Contact |
Aleece Nolasco |
Regulation Number | 866.6080
|
Classification Product Code |
|
Date Received | 03/14/2019 |
Decision Date | 11/09/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Pathology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|