Cleared Traditional

BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 ?g/mL)

K251713 · Becton, Dickinson and Company · Microbiology
Aug 2025
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K251713 is an FDA 510(k) clearance for the BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 ?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 August 8, 2025, 66 days after receiving the submission on June 3, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number K251713 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2025
Decision Date August 08, 2025
Days to Decision 66 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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