BD BACTEC Peds Plus/F Culture Vials (plastic)

System, Blood Culturing

BECTON DICKINSON AND COMPANY

The following data is part of a premarket notification filed by Becton Dickinson And Company with the FDA for Bd Bactec Peds Plus/f Culture Vials (plastic).

Pre-market Notification Details

Device IDK151866
510k NumberK151866
Device Name:BD BACTEC Peds Plus/F Culture Vials (plastic)
ClassificationSystem, Blood Culturing
Applicant BECTON DICKINSON AND COMPANY 7 LOVETON CIRCLE, MC 694 Sparks,  MD  21152
ContactAshanti C. Brown
CorrespondentAshanti C. Brown
BECTON DICKINSON AND COMPANY 7 LOVETON CIRCLE, MC 694 Sparks,  MD  21152
Product CodeMDB  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-09
Decision Date2016-02-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382904420209 K151866 000

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