MAMMAPRINT

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

AGENDIA

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

Pre-market Notification Details

• Device ID: K101454
• 510k Number: K101454
• Device Name: MAMMAPRINT
• Classification: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
• Applicant: AGENDIA SCIENCE PARK 406 Amsterdam, NL 1098sm
• Contact: Guido Brink
• Correspondent: Guido Brink; AGENDIA SCIENCE PARK 406 Amsterdam, NL 1098sm
• Product Code: NYI
• CFR Regulation Number: 866.6040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-05-25
• Decision Date: 2011-01-28
• Summary: summary