K-number	K231568
Device name	HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
Applicant	Hardy Diagnostics
Product code	JTN
Device class	Class II
Decision date	Jul 6, 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 Sulbactam/Durlobactam 10/10µg (SUD20)

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