Device Classification Name |
classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
|
510(k) Number |
K201902 |
Device Name |
MammaPrint |
Applicant |
Agendia Inc. |
22 Morgan |
Irvine,
CA
92618
|
|
Applicant Contact |
Marcelo Trevino |
Correspondent |
Hogan Lovells US LLP |
1735 Market Street Suite 2320 |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice Hogan |
Regulation Number | 866.6040
|
Classification Product Code |
|
Date Received | 07/08/2020 |
Decision Date | 11/05/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|