Medical Device Manufacturer · NL , Amsterdam

Agendia BV - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 2007

3

Total

2

Cleared

1

Denied

FDA 510(k) Regulatory Record - Agendia BV Pathology ✕

3 devices

1-3 of 3

Cleared Jul 21, 2008

MODIFICATION TO MAMMAPRINT

Pathology · 172d

Cleared Jun 22, 2007

Pathology · 102d

Not Cleared Feb 06, 2007

DEN070009 · NYI

Pathology · 7d