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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 K851589
Device Name MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE
Applicant
Preferred Micro-Media
5223 Telegraph Rd.
Toledo,  OH  43612
Applicant Contact ROBERT SCOTT
Correspondent
Preferred Micro-Media
5223 Telegraph Rd.
Toledo,  OH  43612
Correspondent Contact ROBERT SCOTT
Regulation Number866.1700
Classification Product Code
JTZ  
Date Received04/16/1985
Decision Date 04/30/1985
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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