Bioimagene, Inc.

Medical device manufacturer in Sunnyvale, CA.

3510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K092333Pathiam System with Iscan for P53 and KI-67NQN · Traditional 10/27/2010SE
K080910Pathiam System for HER2/NEU Immunohistochemistry Reagents & KitsNOT · Traditional 02/04/2009SE
K062756Pathiam Imaging Software for HER2/NEUNOT · Traditional 02/20/2007SE