MAMMAPRINT

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

AGENDIA BV

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

Pre-market Notification Details

• Device ID: K070675
• 510k Number: K070675
• Device Name: MAMMAPRINT
• Classification: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
• Applicant: AGENDIA BV LOUWESWEG 6 Amsterdam, NL 1066 Ec
• Contact: Guido Brink
• Correspondent: Guido Brink; AGENDIA BV LOUWESWEG 6 Amsterdam, NL 1066 Ec
• Product Code: NYI
• CFR Regulation Number: 866.6040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-03-12
• Decision Date: 2007-06-22
• Summary: summary