Cleared Traditional

VRESELECT CULTURE MEDIUM

K103684 · Bio-Rad · Microbiology
Oct 2011
Decision
308d
Days
Class 2
Risk

About This 510(k) Submission

K103684 is an FDA 510(k) clearance for the VRESELECT CULTURE MEDIUM, a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II — Special Controls, product code JSO), submitted by Bio-Rad (Beverly, US). The FDA issued a Cleared decision on October 21, 2011, 308 days after receiving the submission on December 17, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number K103684 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2010
Decision Date October 21, 2011
Days to Decision 308 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