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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 K192326
Device Name HardyDisk AST Lefamulin 20µg (LMU20)
Applicant
Hardy Diagnostics
1430 West McCoy Lane
Santa Maria,  CA  93455
Applicant Contact Anna Klavins
Correspondent
Hardy Diagnostics
1430 West McCoy Lane
Santa Maria,  CA  93455
Correspondent Contact Anna Klavins
Regulation Number866.1620
Classification Product Code
JTN  
Date Received08/27/2019
Decision Date 09/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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