Imaging :: Tripath imaging receives fda 510(k) clearance for p53 application for ventana image analysis system
TriPath Imaging Inc. (Nasdaq: TPTH) and Ventana Medical Systems, Inc. (Nasdaq: VMSI), announced today that TriPath Imaging has received 510(k) clearance from the U.S. Food and Drug Administration for the Ventana Image Analysis System (VIAS(TM)) when used with tissues stained for p53. In 2005 and 2006, the Companies announced 510(k) clearances for VIAS when used with the Ventana Estrogen Receptor (ER), Progesterone Receptor (PR), Ki-67 and HER- 2/neu assays.