HardyDisk AST Gepotidacin 10µg (GEP10)
FDA 510(k) K250956 · Hardy Diagnostics
510(k) numberK250956
Submission
- Device name
- HardyDisk AST Gepotidacin 10µg (GEP10)
- Applicant
- Hardy Diagnostics
Santa Maria, CA, US - Received
- March 31, 2025
- Decision date
- June 26, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JTN – Susceptibility Test Discs, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1620
- Specialty
- Microbiology
Other 510(k)s with product code JTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262113 | HardyDisk AST Tebipenem 10µg (TBP10)JTN · Traditional | Hardy Diagnostics | 08/20/2026SE |
| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 07/24/2026SE |
| K261853 | Gepotidacin GEP 10 µgJTN · Traditional | Liofilchem, Inc. | 07/23/2026SE |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10)JTN · Traditional | Hardy Diagnostics | 05/11/2026SE |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 12/05/2025SE |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30)JTN · Traditional | Hardy Diagnostics | 11/20/2025SE |
| K251879 | Sulopenem SPM 2 µgJTN · Traditional | Liofilchem | 08/12/2025SE |
| K250885 | Ceftobiprole BPR 5 µg DiscJTN · Traditional | Liofilchem, Inc. | 06/23/2025SE |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 06/12/2025SE |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)JTN · Traditional | Hardy Diagnostics | 05/15/2025SE |
More from Hardy Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K262113 | HardyDisk AST Tebipenem 10µg (TBP10)JTN · Traditional | 08/20/2026SE |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10)JTN · Traditional | 05/11/2026SE |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30)JTN · Traditional | 11/20/2025SE |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)JTN · Traditional | 05/15/2025SE |
| K233534 | Viral Transport MediumJSM · Traditional | 08/02/2024SE |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30)JTN · Traditional | 07/18/2024SE |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)JTN · Traditional | 07/06/2023SE |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5)JTN · Traditional | 06/01/2023SE |
| K193504 | HardyDisk AST Cefiderocol 30ug (FDC30)JTN · Traditional | 01/23/2020SE |
| K192326 | HardyDisk AST Lefamulin 20µg (LMU20)JTN · Traditional | 09/19/2019SE |
Questions and answers
When was HardyDisk AST Gepotidacin 10µg (GEP10) cleared by the FDA?
HardyDisk AST Gepotidacin 10µg (GEP10) (K250956) received a 510(k) decision of Substantially Equivalent on June 26, 2025, 87 days after the submission was received.
What is the product code of K250956?
The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.