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 Eravacycline Disc (20ug) Erv20.
| Device ID | K193508 |
| 510k Number | K193508 |
| Device Name: | Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 |
| 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 | 2019-12-18 |
| Decision Date | 2020-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05032384580231 | K193508 | 000 |