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 Meropenem/vaborbactam Disc (30µg) Mev30.
| Device ID | K181975 |
| 510k Number | K181975 |
| Device Name: | Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | Oxoid Limited (Part Of Thermo Fisher Scientific) Wade Road Basingstoke, GB Rg24 8pw |
| Contact | Philip Brame |
| Correspondent | Philip Brame 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 | 2018-07-24 |
| Decision Date | 2018-09-27 |