BD BACTEC PLUS ANAEROBIC/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 Anaerobic/f (plastic).

Pre-market Notification Details

Device IDK141810
510k NumberK141810
Device Name:BD BACTEC PLUS ANAEROBIC/F (PLASTIC)
ClassificationSystem, Blood Culturing
Applicant Becton, Dickinson And Company 7 Loveton Cir., MC 694 Sparks,  MD  21152
ContactPaul Swift
CorrespondentPaul Swift
Becton, Dickinson And Company 7 Loveton Cir., MC 694 Sparks,  MD  21152
Product CodeMDB  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-07
Decision Date2014-12-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382904420223 K141810 000

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