Skip to content

Bd Phoenix Automated Microbiology System

by Becton, Dickinson & CO 510(k)

Active United States

510(k) K020323

Overview

The Bd Phoenix Automated Microbiology System is an automated microbiology system for the identification and antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram negative and Gram-positive bacteria of human origin. It provides rapid, accurate and reliable detection of known and emerging antimicrobial resistance.

The system is supplied as an automated solution and is classified as a class 2 device. It has been cleared under the FDA 510(k) clearance, specifically K020323. The device is used in microbiology settings and its use is regulated under the regulation number 866.1645. The system is intended for in vitro use and is designed to deliver highly accurate results.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK020323 Date4 Apr 2002ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LON
Device Class
Class II
Regulation
21 CFR Part 866.1645
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Other devices from Becton, Dickinson & Co.

See all devices from Becton, Dickinson & Co. →

Questions

  • What is the BD Phoenix Automated Microbiology System used for?

    The system is used for the identification and antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram negative and Gram-positive bacteria of human origin.

  • Is the BD Phoenix Automated Microbiology System a single-use device?

    The description does not specify if the system is single-use or reusable, but it is classified as a class 2 device and is intended for in vitro use.

  • What is the regulatory classification of the BD Phoenix Automated Microbiology System?

    The system is classified as a class 2 device and has been cleared under the FDA 510(k) clearance, specifically K020323, with a regulation number of 866.1645.