510(k) K092767

BBL CHROMAGAR MRSA II by Becton, Dickinson & CO — Product Code JSO

K092767 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "BBL CHROMAGAR MRSA II". The FDA issued a decision of Substantially Equivalent on August 20, 2010. The device falls under product code JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar), a Class II device regulated under 21 CFR 866.1700. Becton, Dickinson & CO has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2010
Date Received
September 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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