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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 K802957
Device Name MUELLER HINTON BROTH
Applicant
Gibco Laboratories Life Technologies, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Gibco Laboratories Life Technologies, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.1700
Classification Product Code
JTZ  
Date Received11/17/1980
Decision Date 12/22/1980
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
Recalls CDRH Recalls
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