The following data is part of a premarket notification filed by Oxoid Limited (part Of Thermo Fisher Scientific) with the FDA for Thermo Scientific Oxoid Omadacycline Disc (30 Ug) Omc30.
| Device ID | K203336 |
| 510k Number | K203336 |
| Device Name: | Thermo Scientific Oxoid Omadacycline Disc (30 Ug) OMC30 |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | Oxoid Limited (part Of Thermo Fisher Scientific) Wade Road Basingstoke, GB RG24 8PW |
| Contact | Philip Brame |
| Correspondent | Amie Lovatt Oxoid Limited (part Of Thermo Fisher Scientific) Wade Road Basingstoke, GB RG24 8PW |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-12 |
| Decision Date | 2022-09-15 |