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BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25 +3 mo…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K163637

by Becton, Dickinson and Company

Identifiers

510(k) Number
K163637 FDA 510(k)
FDA Product Code
LON FDA 510(k)
Models / Variants
0.25 FDA 510(k)
4- 32 FDA 510(k)
4ug FDA 510(k)
mL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.1645 FDA 510(k)
Regulation Number
866.1645 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BD Phoenix Automated Microbiology System - GN Ceftazidime/Avibactam (0.25/4–32/4 µg/mL) is an automated antimicrobial susceptibility testing system designed for in vitro quantitative determination of minimal inhibitory concentrations (MICs). It identifies Gram-negative aerobic and facultative anaerobic bacteria, including those in the Enterobacteriaceae and non-Enterobacteriaceae families, to assess antimicrobial resistance profiles.

This system is intended for use in clinical microbiology laboratories and operates as a reusable, non-sterile device. The test panels are supplied as single-use consumables, with susceptibility testing performed via automated incubation and detection methods. The device is classified under FDA regulation 866.1645 and holds a Traditional 510(k) clearance (K163637) for microbiology applications, adhering to Class II medical device standards.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0. ..., BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0. ..., BD Phoenix™ panels | BD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company
FDA Applicant
Becton Dickinson & Company

Sources (1)

  • FDA 510(k) K163637 24 fields · synced Sep 18, 2026