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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 K152838
Device Name HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50
Applicant
Hardy Diagnostics
1430 W. Mccoy Lane
Santa Monica,  CA  93455
Applicant Contact WENDY HADLEY
Correspondent
Hardy Diagnostics
1430 W. Mccoy Lane
Santa Monica,  CA  93455
Correspondent Contact WENDY HADLEY
Regulation Number866.1620
Classification Product Code
JTN  
Date Received09/29/2015
Decision Date 11/24/2015
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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