Hardy Diagnostics - FDA 510(k) Cleared Devices
Recent clearances: HardyDisk AST Tebipenem 10µg (TBP10), HardyDisk AST Gepotidacin 10µg (GEP10), HardyDisk AST Cefiderocol 30µg (FDC30)
110
Total
110
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hardy Diagnostics Microbiology ✕
110 devices
Cleared
Aug 20, 2026
HardyDisk AST Tebipenem 10µg (TBP10)
Microbiology
58d
Cleared
May 11, 2026
HardyDisk AST Gepotidacin 10µg (GEP10)
Microbiology
56d
Cleared
Nov 20, 2025
HardyDisk AST Cefiderocol 30µg (FDC30)
Microbiology
57d
Cleared
Jun 26, 2025
HardyDisk AST Gepotidacin 10µg (GEP10)
Microbiology
87d
Cleared
May 15, 2025
HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
Microbiology
86d
Cleared
Aug 02, 2024
Viral Transport Medium
Microbiology
273d
Cleared
Jul 18, 2024
HardyDisk AST Cefiderocol 30µg (FDC30)
Microbiology
91d
Cleared
Jul 06, 2023
HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
Microbiology
36d
Cleared
Jun 01, 2023
HardyDisk AST Rezafungin 5µg (RZF5)
Microbiology
66d
Cleared
Jan 23, 2020
HardyDisk AST Cefiderocol 30ug (FDC30)
Microbiology
36d
Cleared
Sep 19, 2019
HardyDisk AST Lefamulin 20µg (LMU20)
Microbiology
23d
Cleared
Jul 31, 2019
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
Microbiology
12d
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