510(k) K260842
- Device
- HardyDisk AST Gepotidacin 10µg (GEP10)
- Applicant
- Hardy Diagnostics
- 510(k) number
- K260842
- Product code
- JTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-11
- Date received
- 2026-03-16
- Regulation
- 866.1620
- Classification name
- Susceptibility Test Discs, Antimicrobial
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Lauren Hamilton
- Address
- 1430 W. Mccoy Ln. Santa Maria CA US 93455 93455
FDA Registration Numbers
- 3004111573
- 2030652
- 3035367039
- 1119779
- 8020667
- 8010096
- 2022807
- 3013661582
- 2032112
- 3012389632
- 2647876
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JTN
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 | Thermo Fisher Scientific (Oxoid Ltd.) | 2025-12-05 |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | 2025-11-20 |
| K251879 | Sulopenem SPM 2 µg | Liofilchem | 2025-08-12 |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | 2025-06-26 |
| K250885 | Ceftobiprole BPR 5 µg Disc | Liofilchem, Inc. | 2025-06-23 |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 | Thermo Fisher Scientific (Oxoid Ltd.) | 2025-06-12 |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | Hardy Diagnostics | 2025-05-15 |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) | Hardy Diagnostics | 2024-07-18 |
| K231806 | Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2024-03-22 |
| K232276 | Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2023-10-06 |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | Hardy Diagnostics | 2023-07-06 |
| K230651 | BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) | Becton, Dickinson and Company | 2023-06-07 |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | Hardy Diagnostics | 2023-06-01 |
| K221826 | BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) | Becton, Dickinson and Company | 2022-12-21 |
| K203336 | Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 | Oxoid Limited (Part of Thermo Fisher Scientific) | 2022-09-15 |