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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 K172621
Device Name HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
Applicant
Hardy Diagnostics
1430 W. Mccoy Ln.
Santa Maria,  CA  93455
Applicant Contact Andre Hsiung
Correspondent
Hardy Diagnostics
1430 W. Mccoy Ln.
Santa Maria,  CA  93455
Correspondent Contact Andre Hsiung
Regulation Number866.1620
Classification Product Code
JTN  
Date Received08/31/2017
Decision Date 10/03/2017
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
Predetermined Change
Control Plan Authorized		 No
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