Cleared Special

BD Phoenix? Automated Microbiology System

K250344 · Becton, Dickinson and Company · Microbiology
Mar 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K250344 is an FDA 510(k) clearance for the BD Phoenix? Automated Microbiology System, a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II — Special Controls, product code LON), submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on March 6, 2025, 28 days after receiving the submission on February 6, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number K250344 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2025
Decision Date March 06, 2025
Days to Decision 28 days
Submission Type Special
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

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