K-number	K230827
Device name	HardyDisk AST Rezafungin 5µg (RZF5)
Applicant	Hardy Diagnostics
Product code	JTN
Device class	Class II
Decision date	Jun 1, 2023
Decision	Substantially Equivalent
Regulation	866.1620

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Source

View the full FDA submission: accessdata.fda.gov

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HardyDisk AST Rezafungin 5µg (RZF5)

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