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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, Mueller Hinton Agar/Broth
510(k) Number K132491
Device Name MUELLER HINTON AGAR
Applicant
Edge Biologicals, Inc.
598 N. Second St.
Memphis,  TN  38105
Applicant Contact TED A PEARSON
Correspondent
Edge Biologicals, Inc.
598 N. Second St.
Memphis,  TN  38105
Correspondent Contact TED A PEARSON
Regulation Number866.1700
Classification Product Code
JTZ  
Date Received08/08/2013
Decision Date 06/30/2014
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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