The following data is part of a premarket notification filed by Omnyx, Llc with the FDA for Omnyx Idp For Her2 Manual Application.
| Device ID | K131140 |
| 510k Number | K131140 |
| Device Name: | OMNYX IDP FOR HER2 MANUAL APPLICATION |
| Classification | Automated Digital Image Manual Interpretation Microscope |
| Applicant | OMNYX, LLC 62 FOREST STREET, SUITE 300 Marlborough, MA 01752 |
| Contact | Gail E Radcliffe |
| Correspondent | Gail E Radcliffe OMNYX, LLC 62 FOREST STREET, SUITE 300 Marlborough, MA 01752 |
| Product Code | OEO |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-22 |
| Decision Date | 2014-04-01 |
| Summary: | summary |