BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 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-nitrofurantoin (gp) 4-128 Ug/ml.

Pre-market Notification Details

Device IDK082852
510k NumberK082852
Device Name:BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks,  MD  21152 -0999
ContactJanine Matlak
CorrespondentJanine Matlak
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 Received2008-09-29
Decision Date2009-01-29
Summary:summary

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