Name: Predicase
Price: 199 USD

K-number	K253105
Device name	HardyDisk AST Cefiderocol 30µg (FDC30)
Applicant	Hardy Diagnostics
Product code	JTN
Device class	Class II
Decision date	Nov 20, 2025
Decision	Substantially Equivalent
Regulation	866.1620

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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HardyDisk AST Cefiderocol 30µg (FDC30)

Everything you need for a 510(k) submission. Nothing you don't.