Cleared Traditional

chromID MRSA

K151688 · bioMerieux, Inc. · Microbiology

Mar 2016

Decision

262d

Days

Class 2

Risk

About This 510(k) Submission

K151688 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 March 11, 2016, 262 days after receiving the submission on June 23, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number	K151688 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2015
Decision Date	March 11, 2016
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