Cleared Traditional

BD Phoenix? Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 ?g/mL)

K250447 · Becton, Dickinson and Company · Microbiology
May 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K250447 is an FDA 510(k) clearance for the BD Phoenix? Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 ?g/mL), 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 May 19, 2025, 90 days after receiving the submission on February 18, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number K250447 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2025
Decision Date May 19, 2025
Days to Decision 90 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

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