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Bd Phoenix Automated Microbiology System-Linezolid-Gram Positive

by Becton, Dickinson & CO

510(k) K040006

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040006 Date27 Feb 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BD Phoenix Automated Microbiology System Linezolid Gram Positive is an automated antimicrobial susceptibility testing system designed for Gram-positive bacteria. It performs rapid identification and susceptibility testing, including resistance profiling to linezolid, to aid in the selection of appropriate antimicrobial therapy.

This system is intended for use in clinical microbiology laboratories and is supplied as a reusable instrument with disposable consumables. It operates under controlled laboratory conditions and is regulated under FDA 510K clearance (K040006). The device adheres to Class II medical device standards and is intended for in vitro diagnostic use, with no specific sterility or MRI safety requirements stated.

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