BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 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-meropenem (strep) 0.03125-2 Ug/ml.

Pre-market Notification Details

Device IDK050946
510k NumberK050946
Device Name:BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 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 Received2005-04-15
Decision Date2005-05-27
Summary:summary

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