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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 K854451
Device Name MUELLER HINTON MEDIUM
Applicant
R. Kent Richards, Inc.
45 W. Center
Pl. Grove,  UT  84062
Applicant Contact KENT RICHARDS
Correspondent
R. Kent Richards, Inc.
45 W. Center
Pl. Grove,  UT  84062
Correspondent Contact KENT RICHARDS
Regulation Number866.1700
Classification Product Code
JTZ  
Date Received11/05/1985
Decision Date 11/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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