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 Lefamulin Disc (20µg) Lmu20.
| Device ID | K210873 |
| 510k Number | K210873 |
| Device Name: | Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 |
| 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 | 2021-03-24 |
| Decision Date | 2021-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05032384526123 | K210873 | 000 |