Cleared Traditional

MRSASELECT - EXTENDED INCUBATION

K081212 · Bio-Rad · Microbiology
Jun 2008
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K081212 is an FDA 510(k) clearance for the MRSASELECT - EXTENDED INCUBATION, 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 June 13, 2008, 45 days after receiving the submission on April 29, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number K081212 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2008
Decision Date June 13, 2008
Days to Decision 45 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