BD Phoenix Automated Microbiology System - Ciprofloxacin GN

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

510(k) Number

K052269 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Bd Phoenix Automated Microbiology System-Vancomycin Gram Positive

  Class II

  FDA 510(k) K030677 Active Cleared 1 Apr 2003

• BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit

  Class II

  FDA 510(k) K152870 Active Cleared 27 Oct 2015

• Bd Phoenix Automated Microbiology System-Pipercillin (Gn) 0.5-128 Ug/Ml

  Class II

  FDA 510(k) K041572 Active Cleared 12 Aug 2004

• Bd Probetec Neisseria Gonorrhoeae (Gc) Qx Amplified DNA Assay

  Class II

  FDA 510(k) K090827 Active Cleared 27 May 2009

• Bd Pen Needle

  Class II

  FDA 510(k) K051899 Active Cleared 13 Sep 2005

• Bd Phoenix Automated Microbiology System, Vancomycin (Strep) 0.0625 -32 Ug/Ml

  Class II

  FDA 510(k) K050745 Active Cleared 29 Apr 2005

See all devices from Becton, Dickinson & Co. →

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

  It is used for in vitro rapid identification and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) for clinically significant aerobic and facultative anaerobic Gram-negative and Gram-positive bacteria in clinical microbiology laboratories.

• How is the BD Phoenix Automated Microbiology System - Ciprofloxacin GN supplied?

  It is supplied as a test system for use in clinical microbiology laboratories and is intended for in vitro diagnostic use.

• What regulatory clearance does the BD Phoenix Automated Microbiology System - Ciprofloxacin GN have?

  It has received FDA 510(k) clearance under product code LON and regulation number 866.1645, and is classified as a Class II medical device.