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Hardy Diagnostics FDA Approvals
0 new drug approvals and 9 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| HardyDisk AST Tebipenem 10µg (TBP10)510(k)Aug 20, 2026Microbiology |
| HardyDisk AST Gepotidacin 10µg (GEP10)510(k)May 11, 2026Microbiology |
| HardyDisk AST Cefiderocol 30µg (FDC30)510(k)Nov 20, 2025Microbiology |
| HardyDisk AST Gepotidacin 10µg (GEP10)510(k)Jun 26, 2025Microbiology |
| HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)510(k)May 15, 2025Microbiology |
| Viral Transport Medium510(k)Aug 2, 2024Microbiology |
| HardyDisk AST Cefiderocol 30µg (FDC30)510(k)Jul 18, 2024Microbiology |
| HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)510(k)Jul 6, 2023Microbiology |
| HardyDisk AST Rezafungin 5µg (RZF5)510(k)Jun 1, 2023Microbiology |