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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 K193504
Device Name HardyDisk AST Cefiderocol 30ug (FDC30)
Applicant
Hardy Diagnostics
1430 West McCoy Lane
santa maria,  CA  93455
Applicant Contact rianna malherbe
Correspondent
Hardy Diagnostics
1430 West McCoy Lane
santa maria,  CA  93455
Correspondent Contact rianna malherbe
Regulation Number866.1620
Classification Product Code
JTN  
Date Received12/18/2019
Decision Date 01/23/2020
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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