Cleared Traditional

VRESELECT CULTURE MEDIUM

K122187 · Bio-Rad · Microbiology
Nov 2012
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K122187 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 November 6, 2012, 105 days after receiving the submission on July 24, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number K122187 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2012
Decision Date November 06, 2012
Days to Decision 105 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