BD BACTEC PLUS AEROBIC/F (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 Plus Aerobic/f (plastic).

Pre-market Notification Details

Device IDK113558
510k NumberK113558
Device Name:BD BACTEC PLUS AEROBIC/F (PLASTIC)
ClassificationSystem, Blood Culturing
Applicant Becton, Dickinson And Company 7 LOVETON CIRCLE MC 614 Sparks,  MD  21043
ContactPaul Swift
CorrespondentPaul Swift
Becton, Dickinson And Company 7 LOVETON CIRCLE MC 614 Sparks,  MD  21043
Product CodeMDB  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-01
Decision Date2012-03-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382904420230 K113558 000

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