BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth With Resins In A Plastic Vial

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 Soybean-casein Digest Broth With Resins In A Plastic Vial.

Pre-market Notification Details

Device IDK173873
510k NumberK173873
Device Name:BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth With Resins In A Plastic Vial
ClassificationSystem, Blood Culturing
Applicant Becton Dickinson And Company 7 Loveton Circle MC:694 Sparks,  MD  21152
ContactAshanti Brown
CorrespondentAshanti 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 Received2017-12-20
Decision Date2018-03-16
Summary:summary

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