510(k) K262163

BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth by Becton Dickinson and Company — Product Code JTZ

K262163 is an FDA 510(k) premarket notification submitted by Becton Dickinson and Company for the device "BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth". The FDA issued a decision of Substantially Equivalent on September 14, 2026. The device falls under product code JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth), a Class II device regulated under 21 CFR 866.1700. Becton Dickinson and Company has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2026
Date Received
June 26, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Device Class
Class II
Regulation Number
866.1700
Review Panel
MI
Submission Type