MammaPrint FFPE NGS Kit

Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

Agendia Inc.

The following data is part of a premarket notification filed by Agendia Inc. with the FDA for Mammaprint Ffpe Ngs Kit.

Pre-market Notification Details

Device IDK210973
510k NumberK210973
Device Name:MammaPrint FFPE NGS Kit
ClassificationClassifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Applicant Agendia Inc. 22 Morgan Irvine,  CA  92618
ContactMarcelo Trevino
CorrespondentMarcelo Trevino
Agendia Inc. 22 Morgan Irvine,  CA  92618
Product CodeNYI  
CFR Regulation Number866.6040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-31
Decision Date2022-09-08

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.