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Bioimagene, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K092333PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67October 27, 2010
K080910PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITSFebruary 4, 2009
K062756PATHIAM IMAGING SOFTWARE FOR HER2/NEUFebruary 20, 2007