HardyDisk AST Cefiderocol 30µg (FDC30)
K-Number: K241060 · 2024-07-18
ApplicantHardy Diagnostics
Decision Date2024-07-18
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 2024-07-18 under approval number K241060. 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 2024-07-18. It is manufactured by Hardy Diagnostics. The 510(k) number is K241060.
When was HardyDisk AST Cefiderocol 30µg (FDC30) approved by the FDA?
HardyDisk AST Cefiderocol 30µg (FDC30) received FDA 510(k) clearance on 2024-07-18, under approval number K241060.
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.
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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.