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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 K262163
Device Name BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth
Applicant
Becton Dickinson and Company
7 Loveton Cir.
Sparks,  MD  21152
Applicant Contact Danielle Hilligoss
Correspondent
Becton Dickinson and Company
7 Loveton Cir.
Sparks,  MD  21152
Correspondent Contact Danielle Hilligoss
Regulation Number866.1700
Classification Product Code
JTZ  
Date Received06/26/2026
Decision Date 09/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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