Cleared Traditional

chromID MRSA

K162076 · bioMerieux, Inc. · Microbiology
Oct 2016
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K162076 is an FDA 510(k) clearance for the chromID MRSA, a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II — Special Controls, product code JSO), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on October 25, 2016, 90 days after receiving the submission on July 27, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number K162076 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2016
Decision Date October 25, 2016
Days to Decision 90 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