Omnyx Llc
FDA Regulatory Profile
Omnyx Llc appears in FDA public data with 1 recall, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0469-2014, Class II) was initiated on October 1, 2013. Its most recent 510(k) clearance was granted on April 1, 2014.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0469-2014 | Class II | Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology syste | October 1, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K131140 | OMNYX IDP FOR HER2 MANUAL APPLICATION | April 1, 2014 |