BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth— 510(k) K262163
Substantially EquivalentBecton Dickinson and Company
FDA 510(k) clearance K262163 for BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth, Substantially Equivalent on 2026-09-14. Applicant: Becton Dickinson and Company. Device class: 2.
Summary
Becton Dickinson and Company filed two media under product code JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth): BD BBL Mueller Hinton II Broth (Cation-Adjusted) and BD Difco Mueller Hinton Broth. The record has no other detail on them.
Class II, 21 CFR 866.1700. Microbiology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
BD filed from Sparks, Maryland. The decision came 80 calendar days after FDA received it (June 26 to September 14, 2026).
Clearance details
- Applicant
- Becton Dickinson and Company
- Product code
- Product code JTZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.1700
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.