BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Becton, Dickinson And Company

The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Phoenix Automated Microbiology System- Meropenem (0.125-32 Ug/ml).

Pre-market Notification Details

Device IDK132674
510k NumberK132674
Device Name:BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant Becton, Dickinson And Company 7 LOVETON CIRCLE, MC 614 Sparks,  MD  21152
ContactMonica E Giguere
CorrespondentMonica E Giguere
Becton, Dickinson And Company 7 LOVETON CIRCLE, MC 614 Sparks,  MD  21152
Product CodeLON  
Subsequent Product CodeJWY
Subsequent Product CodeLRG
Subsequent Product CodeLTT
Subsequent Product CodeLTW
CFR Regulation Number866.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-27
Decision Date2013-12-27
Summary:summary

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