Cleared Traditional

BBL CHROMAGAR MRSA II

K092767 · Becton, Dickinson & CO · Microbiology
Aug 2010
Decision
345d
Days
Class 2
Risk

About This 510(k) Submission

K092767 is an FDA 510(k) clearance for the BBL CHROMAGAR MRSA II, a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II — Special Controls, product code JSO), submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on August 20, 2010, 345 days after receiving the submission on September 9, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number K092767 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2009
Decision Date August 20, 2010
Days to Decision 345 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JSO — Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1700