Omnyx Llc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0469-2014Class IIDigital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology systeOctober 1, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K131140OMNYX IDP FOR HER2 MANUAL APPLICATIONApril 1, 2014