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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Discs, Antimicrobial
510(k) Number K260842
Device Name HardyDisk AST Gepotidacin 10µg (GEP10)
Applicant
Hardy Diagnostics
1430 W. Mccoy Ln.
Santa Maria,  CA  93455
Applicant Contact Lauren Hamilton
Correspondent
Hardy Diagnostics
1430 W. Mccoy Ln.
Santa Maria,  CA  93455
Correspondent Contact Lauren Hamilton
Regulation Number866.1620
Classification Product Code
JTN  
Date Received03/16/2026
Decision Date 05/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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