Cleared Traditional

CHROMID CARBA agar (CARB)

K181092 · Biomerieux S.A. · Microbiology

Jul 2018

Decision

72d

Days

Class 2

Risk

About This 510(k) Submission

K181092 is an FDA 510(k) clearance for the CHROMID CARBA agar (CARB), a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II — Special Controls, product code JSO), submitted by Biomerieux S.A. (Marcy-L'?toile, FR). The FDA issued a Cleared decision on July 6, 2018, 72 days after receiving the submission on April 25, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number	K181092 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 25, 2018
Decision Date	July 06, 2018
Days to Decision	72 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