Medical Device Manufacturer · NL , Amsterdam

Agendia - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2009

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Agendia Pathology ✕

3 devices

1-3 of 3

Cleared Jan 23, 2015

MAMMAPRINT FFPE

Pathology · 266d

Cleared Jan 28, 2011

Pathology · 248d

Cleared Dec 11, 2009

MODIFICATION TO MAMMAPRINT

Pathology · 603d