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FDA 510(k) Applications Submitted by Indu Lakshman
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180660
03/14/2018
Avanti
Optovue, Inc.
K080910
04/01/2008
PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS
BIOIMAGENE, INC.
K111543
06/02/2011
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
VENTANA MEDICAL SYSTEMS, INC.
K092333
08/04/2009
PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67
BIOIMAGENE, INC.
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