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510(k) K241060

HardyDisk AST Cefiderocol 30µg (FDC30) by Hardy Diagnostics — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2024
Date Received
April 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type

Other clearances by Hardy Diagnostics

  • K253105 — HardyDisk AST Cefiderocol 30µg (FDC30) (November 20, 2025)
  • K250956 — HardyDisk AST Gepotidacin 10µg (GEP10) (June 26, 2025)
  • K250454 — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) (May 15, 2025)
  • K233534 — Viral Transport Medium (August 2, 2024)
  • K231568 — HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) (July 6, 2023)
  • K230827 — HardyDisk AST Rezafungin 5µg (RZF5) (June 1, 2023)
  • K193504 — HardyDisk AST Cefiderocol 30ug (FDC30) (January 23, 2020)
  • K192326 — HardyDisk AST Lefamulin 20µg (LMU20) (September 19, 2019)
  • K191931 — HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) (July 31, 2019)
  • K190553 — HardyCHROM CRE (April 29, 2019)

Other clearances for product code JTN

  • K251337 — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 (December 5, 2025)
  • K253105 — HardyDisk AST Cefiderocol 30µg (FDC30) (November 20, 2025)
  • K251879 — Sulopenem SPM 2 µg (August 12, 2025)
  • K250956 — HardyDisk AST Gepotidacin 10µg (GEP10) (June 26, 2025)
  • K250885 — Ceftobiprole BPR 5 µg Disc (June 23, 2025)
  • K250789 — Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 (June 12, 2025)
  • K250454 — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) (May 15, 2025)
  • K231806 — Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 (March 22, 2024)
  • K232276 — Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 (October 6, 2023)
  • K231568 — HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) (July 6, 2023)