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FDA 510(k) Applications Submitted by BIOIMAGENE, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K062756
09/14/2006
PATHIAM IMAGING SOFTWARE FOR HER2/NEU
BIOIMAGENE, INC.
K080910
04/01/2008
PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS
BIOIMAGENE, INC.
K092333
08/04/2009
PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67
BIOIMAGENE, INC.
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