HardyDisk AST Rezafungin 5µg (RZF5)
K-Number: K230827 · 2023-06-01
ApplicantHardy Diagnostics
Decision Date2023-06-01
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
HardyDisk AST Rezafungin 5µg (RZF5) is a medical device manufactured by Hardy Diagnostics. It received FDA 510(k) clearance on 2023-06-01 under approval number K230827. 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 Rezafungin 5µg (RZF5)?
HardyDisk AST Rezafungin 5µg (RZF5) is a medical device that received FDA 510(k) clearance on 2023-06-01. It is manufactured by Hardy Diagnostics. The 510(k) number is K230827.
When was HardyDisk AST Rezafungin 5µg (RZF5) approved by the FDA?
HardyDisk AST Rezafungin 5µg (RZF5) received FDA 510(k) clearance on 2023-06-01, under approval number K230827.
What company makes HardyDisk AST Rezafungin 5µg (RZF5)?
HardyDisk AST Rezafungin 5µg (RZF5) is manufactured by Hardy Diagnostics.
What is the FDA product code for HardyDisk AST Rezafungin 5µg (RZF5)?
The FDA product code for HardyDisk AST Rezafungin 5µg (RZF5) is JTN.
Other Devices by Hardy Diagnostics
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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.