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510(k) K230827

HardyDisk AST Rezafungin 5µg (RZF5) by Hardy Diagnostics — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2023
Date Received
March 27, 2023
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)
  • K241060 — HardyDisk AST Cefiderocol 30µg (FDC30) (July 18, 2024)
  • K231568 — HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) (July 6, 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)
  • K241060 — HardyDisk AST Cefiderocol 30µg (FDC30) (July 18, 2024)
  • 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)