MammaPrint

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.

Pre-market Notification Details

Device IDK201902
510k NumberK201902
Device Name:MammaPrint
ClassificationClassifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Applicant Agendia Inc. 22 Morgan Irvine,  CA  92618
ContactMarcelo Trevino
CorrespondentJanice Hogan
Hogan Lovells US LLP 1735 Market Street Suite 2320 Philadelphia,  PA  19103
Product CodeNYI  
CFR Regulation Number866.6040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-08
Decision Date2020-11-05

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