Cleared Traditional

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)

K123404 · Becton, Dickinson & CO · Microbiology

Jun 2013

Decision

234d

Days

Class 2

Risk

About This 510(k) Submission

K123404 is an FDA 510(k) clearance for the BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML), a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II — Special Controls, product code LON), submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on June 27, 2013, 234 days after receiving the submission on November 5, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K123404 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 2012
Decision Date	June 27, 2013
Days to Decision	234 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1645