Cleared Traditional

MRSASELECT

K070361 · Bio-Rad · Microbiology
Sep 2007
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K070361 is an FDA 510(k) clearance for the MRSASELECT, 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 September 13, 2007, 218 days after receiving the submission on February 7, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number K070361 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2007
Decision Date September 13, 2007
Days to Decision 218 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