JTN
- Product code
- JTN
- Device name
- Susceptibility Test Discs, Antimicrobial
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.1620
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 14
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 331 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (14)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262113 | 2026-08-20 | Hardy Diagnostics | HardyDisk AST Tebipenem 10µg (TBP10) | — |
| K261781 | 2026-07-24 | Thermo Fisher Scientific (Oxoid Ltd.) | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30… | — |
| K261853 | 2026-07-23 | Liofilchem, Inc. | Gepotidacin GEP 10 µg | — |
| K260842 | 2026-05-11 | Hardy Diagnostics | HardyDisk AST Gepotidacin 10µg (GEP10) | — |
| K251337 | 2025-12-05 | Thermo Fisher Scientific (Oxoid Ltd.) | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP… | — |
| K253105 | 2025-11-20 | Hardy Diagnostics | HardyDisk AST Cefiderocol 30µg (FDC30) | — |
| K251879 | 2025-08-12 | Liofilchem | Sulopenem SPM 2 µg | — |
| K250956 | 2025-06-26 | Hardy Diagnostics | HardyDisk AST Gepotidacin 10µg (GEP10) | — |
| K250885 | 2025-06-23 | Liofilchem, Inc. | Ceftobiprole BPR 5 µg Disc | — |
| K250789 | 2025-06-12 | Thermo Fisher Scientific (Oxoid Ltd.) | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30… | — |
| K250454 | 2025-05-15 | Hardy Diagnostics | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | — |
| K241060 | 2024-07-18 | Hardy Diagnostics | HardyDisk AST Cefiderocol 30µg (FDC30) | — |
| K231806 | 2024-03-22 | Oxoid Limited (Part of Thermo Fisher S… | Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 | — |
| K232276 | 2023-10-06 | Oxoid Limited (Part of Thermo Fisher S… | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (… | — |
Official FDA classification page: JTN
Classification and pathway per current FDA publications. Data from openFDA (CC0).