BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

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.

Pre-market Notification Details

Device IDK020321
510k NumberK020321
Device Name:BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
ClassificationSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Applicant BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks,  MD  21152 -0999
ContactBradford M Spring
CorrespondentBradford M Spring
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 Received2002-01-15
Decision Date2002-05-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382902460115 K020321 000
30382902460061 K020321 000
30382902460047 K020321 000
30382902460030 K020321 000
00382902460169 K020321 000
00382902460152 K020321 000
00382904436247 K020321 000

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