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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gbs Culture Media, Selective And Differential
510(k) Number K170481
Device Name Strep B Carrot Broth Kit
Applicant
Hardy Diagnostics
1430 W. Mccoy Lane
Santa Monica,  CA  93455
Applicant Contact Rianna Malherbe
Correspondent
Hardy Diagnostics
1430 W. Mccoy Lane
Santa Monica,  CA  93455
Correspondent Contact Rianna Malherbe
Regulation Number866.2360
Classification Product Code
PQZ  
Date Received02/16/2017
Decision Date 05/16/2017
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
Predetermined Change
Control Plan Authorized		 No
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