HardyDisk AST Cefiderocol 30µg (FDC30)
K-Number: K253105 · 2025-11-20
ApplicantHardy Diagnostics
Decision Date2025-11-20
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
HardyDisk AST Cefiderocol 30µg (FDC30) is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2025-11-20 under approval number K253105. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HardyDisk AST Cefiderocol 30µg (FDC30)?
HardyDisk AST Cefiderocol 30µg (FDC30) is a medical device that received FDA 510(k) clearance on 2025-11-20. It is manufactured by Hardy Diagnostics. The 510(k) number is K253105.
When was HardyDisk AST Cefiderocol 30µg (FDC30) approved by the FDA?
HardyDisk AST Cefiderocol 30µg (FDC30) received FDA 510(k) clearance on 2025-11-20, under approval number K253105.
What company makes HardyDisk AST Cefiderocol 30µg (FDC30)?
HardyDisk AST Cefiderocol 30µg (FDC30) is manufactured by Hardy Diagnostics.
What is the FDA product code for HardyDisk AST Cefiderocol 30µg (FDC30)?
The FDA product code for HardyDisk AST Cefiderocol 30µg (FDC30) is JTN.
Other Devices by Hardy Diagnostics
Related Devices (Code: JTN)
K172621HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)Hardy Diagnostics
K171975HardyDisk AST Delafloxacin 5 µg (DLX5)Hardy Diagnostics
K170127HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40Hardy Diagnostics
K181975Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30Oxoid Limited (Part of Thermo Fisher Scientific)
K182357HardyDisk AST Eravacycline 20µg (ERV20)Hardy Diagnostics
K181700HardyDisk AST Plazomicin 30ug (PLZ30)Hardy Diagnostics
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.