510(k) K262163
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