JTN — Susceptibility Test Discs, Antimicrobial Class II
FDA product code JTN covers "Susceptibility Test Discs, Antimicrobial", a Class II medical device regulated under 21 CFR 866.1620. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JTN
- Device Class
- Class II
- Regulation Number
- 866.1620
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260842 | hardy diagnostics | HardyDisk AST Gepotidacin 10µg (GEP10) | May 11, 2026 |
| K251337 | thermo fisher scientific (oxoid ltd.) | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | December 5, 2025 |
| K253105 | hardy diagnostics | HardyDisk AST Cefiderocol 30µg (FDC30) | November 20, 2025 |
| K251879 | liofilchem | Sulopenem SPM 2 µg | August 12, 2025 |
| K250956 | hardy diagnostics | HardyDisk AST Gepotidacin 10µg (GEP10) | June 26, 2025 |
| K250885 | liofilchem | Ceftobiprole BPR 5 µg Disc | June 23, 2025 |
| K250789 | thermo fisher scientific (oxoid ltd.) | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 | June 12, 2025 |
| K250454 | hardy diagnostics | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | May 15, 2025 |
| K241060 | hardy diagnostics | HardyDisk AST Cefiderocol 30µg (FDC30) | July 18, 2024 |
| K231806 | oxoid limited (part of thermo fisher scientific) | Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 | March 22, 2024 |
| K232276 | oxoid limited (part of thermo fisher scientific) | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 | October 6, 2023 |
| K231568 | hardy diagnostics | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | July 6, 2023 |
| K230651 | becton, dickinson and | BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) | June 7, 2023 |
| K230827 | hardy diagnostics | HardyDisk AST Rezafungin 5µg (RZF5) | June 1, 2023 |
| K221826 | becton, dickinson and | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) | December 21, 2022 |
| K203336 | oxoid limited (part of thermo fisher scientific) | Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 | September 15, 2022 |
| K210873 | oxoid limited (part of thermo fisher scientific) | Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 | October 27, 2021 |
| K203700 | oxoid limited (part of thermo fisher scientific) | Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 | July 30, 2021 |
| K193508 | oxoid limited (part of thermo fisher scientific) | Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 | December 4, 2020 |
| K193504 | hardy diagnostics | HardyDisk AST Cefiderocol 30ug (FDC30) | January 23, 2020 |