BD BACTEC PLUS AEROBIC/F BLOOD CULTURE MEDIUM

System, Blood Culturing

BECTON, DICKINSON & CO.

The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Bactec Plus Aerobic/f Blood Culture Medium.

Pre-market Notification Details

Device IDK083572
510k NumberK083572
Device Name:BD BACTEC PLUS AEROBIC/F BLOOD CULTURE MEDIUM
ClassificationSystem, Blood Culturing
Applicant BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks,  MD  21152
ContactDennis Mertz
CorrespondentDennis Mertz
BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks,  MD  21152
Product CodeMDB  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-03
Decision Date2008-12-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382904421923 K083572 000

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