Ikonisys, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K080909ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000October 17, 2008
K062755IKONISCOPE ONCOFISH BLADDER TEST SYSTEMJanuary 4, 2007
K061392IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEMAugust 1, 2006
K052577IKONISCOPE FASTFISH AMNIO IMAGING SYSTEMJanuary 24, 2006