BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

BECTON, DICKINSON & CO.

The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Phoenix Automated Microbiology System - Vancomycin (0.5-32 Ug/ml).

Pre-market Notification Details

Device IDK131331
510k NumberK131331
Device Name:BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks,  MD  21152 -0999
ContactMonica E Giguere
CorrespondentMonica E Giguere
BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks,  MD  21152 -0999
Product CodeLON  
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-09
Decision Date2013-07-10
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.