Cleared Traditional

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)

K131331 · Becton, Dickinson & CO · Microbiology

Jul 2013

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K131331 is an FDA 510(k) clearance for the BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 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 July 10, 2013, 62 days after receiving the submission on May 9, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K131331 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2013
Decision Date	July 10, 2013
Days to Decision	62 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