Cleared Traditional

BD Phoenix? Automated Microbiology System - GN Ciprofloxacin (0.0156?4 ?g/mL)

K233986 · Becton, Dickinson and Company · Microbiology
Mar 2024
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K233986 is an FDA 510(k) clearance for the BD Phoenix? Automated Microbiology System - GN Ciprofloxacin (0.0156?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 March 15, 2024, 88 days after receiving the submission on December 18, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number K233986 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2023
Decision Date March 15, 2024
Days to Decision 88 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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