FDA 510(k)

BD Phoenix Automated Microbiology System

K-Number: K250344 · 2025-03-06

Decision Date2025-03-06

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BD Phoenix Automated Microbiology System is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2025-03-06 under approval number K250344. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Phoenix Automated Microbiology System?

BD Phoenix Automated Microbiology System is a medical device that received FDA 510(k) clearance on 2025-03-06. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K250344.

When was BD Phoenix Automated Microbiology System approved by the FDA?

BD Phoenix Automated Microbiology System received FDA 510(k) clearance on 2025-03-06, under approval number K250344.

What company makes BD Phoenix Automated Microbiology System?

BD Phoenix Automated Microbiology System is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD Phoenix Automated Microbiology System?

The FDA product code for BD Phoenix Automated Microbiology System is LON.

Related Clinical Trials

NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT00739362 Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment RECRUITING NCT06689553 Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure TERMINATED

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Becton, Dickinson and Company

K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe K162516BD Pen Needle K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube K151589BD MAX CT/GC/TV, BD MAX INSTRUMENT K151870BD U-500 INSULIN SYRINGE K161553BD SafeAssist

View all 100 devices →

Related Devices (Code: LON)

K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc. K152075VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)bioMerieux, Inc. K151320BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/mlBecton, Dickinson and Company K172944VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mLbioMerieux, Inc. K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc. K162737VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)bioMerieux, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.