Medical Device Manufacturer · US , Cupertino , CA

Bioimagene, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2007
3
Total
3
Cleared
0
Denied

FDA 510(k) Regulatory Record - Bioimagene, Inc. Pathology ✕

3 devices
1-3 of 3
Cleared Oct 27, 2010
PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67
K092333 · NQN
Pathology · 449d
Cleared Feb 04, 2009
PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS
K080910 · NOT
Pathology · 309d
Cleared Feb 20, 2007
PATHIAM IMAGING SOFTWARE FOR HER2/NEU
K062756 · NOT
Pathology · 159d
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