Device Classification Name |
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
|
510(k) Number |
K080252 |
FOIA Releasable 510(k) |
K080252
|
Device Name |
MODIFICATION TO MAMMAPRINT |
Applicant |
AGENDIA BV |
LOUWESWEG 6 |
AMSTERDAM,
NL
1066 EC
|
|
Applicant Contact |
Guido Brink |
Correspondent |
AGENDIA BV |
LOUWESWEG 6 |
AMSTERDAM,
NL
1066 EC
|
|
Correspondent Contact |
Guido Brink |
Regulation Number | 866.6040
|
Classification Product Code |
|
Date Received | 01/31/2008 |
Decision Date | 07/21/2008 |
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
|
Recalls |
CDRH Recalls
|
|
|