Hardy Diagnostics
FDA 510(k) & PMA Approved Devices — 22 products
Total Devices22
Categories4
Latest FDA decision2026-05-11
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | JTN | 2026-05-11 | View |
| 510(k) | K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | JTN | 2025-11-20 | View |
| 510(k) | K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | JTN | 2025-06-26 | View |
| 510(k) | K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | JTN | 2025-05-15 | View |
| 510(k) | K233534 | Viral Transport Medium | JSM | 2024-08-02 | View |
| 510(k) | K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) | JTN | 2024-07-18 | View |
| 510(k) | K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | JTN | 2023-07-06 | View |
| 510(k) | K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | JTN | 2023-06-01 | View |
| 510(k) | K193504 | HardyDisk AST Cefiderocol 30ug (FDC30) | JTN | 2020-01-23 | View |
| 510(k) | K192326 | HardyDisk AST Lefamulin 20µg (LMU20) | JTN | 2019-09-19 | View |
| 510(k) | K191931 | HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) | JTN | 2019-07-31 | View |
| 510(k) | K190553 | HardyCHROM CRE | JSO | 2019-04-29 | View |
| 510(k) | K183298 | HardyDisk AST Omadacycline 30µg (OMC30) | JTN | 2019-01-18 | View |
| 510(k) | K182357 | HardyDisk AST Eravacycline 20µg (ERV20) | JTN | 2018-09-26 | View |
| 510(k) | K181700 | HardyDisk AST Plazomicin 30ug (PLZ30) | JTN | 2018-07-10 | View |
| 510(k) | K173903 | Granada Medium | PQZ | 2018-03-22 | View |
| 510(k) | K172621 | HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) | JTN | 2017-10-03 | View |
| 510(k) | K171975 | HardyDisk AST Delafloxacin 5 µg (DLX5) | JTN | 2017-08-01 | View |
| 510(k) | K170586 | Strep B Carrot Broth One-Step | PQZ | 2017-05-22 | View |
| 510(k) | K170481 | Strep B Carrot Broth Kit | PQZ | 2017-05-16 | View |
No matching devices.
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