Cleared Traditional

MRSASelect II

K171061 · Bio-Rad · Microbiology
Dec 2017
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K171061 is an FDA 510(k) clearance for the MRSASelect II, a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II — Special Controls, product code JSO), submitted by Bio-Rad (92430 Marnes-La-Coquette, FR). The FDA issued a Cleared decision on December 28, 2017, 262 days after receiving the submission on April 10, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number K171061 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2017
Decision Date December 28, 2017
Days to Decision 262 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