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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 K963036
Device Name MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
Applicant
Becton Dickinson Microbiology Systems
P.O. Box 243
Cockeysville,  MD  21030
Applicant Contact VIRGINIA C WEINKNECHT
Correspondent
Becton Dickinson Microbiology Systems
P.O. Box 243
Cockeysville,  MD  21030
Correspondent Contact VIRGINIA C WEINKNECHT
Regulation Number866.1700
Classification Product Code
JTZ  
Date Received08/05/1996
Decision Date 10/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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