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
K141142 · NYI
Pathology · 266d
Cleared Jan 28, 2011
MAMMAPRINT
K101454 · NYI
Pathology · 248d
Cleared Dec 11, 2009
MODIFICATION TO MAMMAPRINT
K081092 · NYI
Pathology · 603d
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