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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
510(k) Number K190553
Device Name HardyCHROM CRE
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 Number866.1700
Classification Product Code
JSO  
Date Received03/05/2019
Decision Date 04/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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