BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth In A Plastic Vial

System, Blood Culturing

BECTON DICKINSON

The following data is part of a premarket notification filed by Becton Dickinson with the FDA for Bd Bactec Standard/10 Aerobic/f Culture Vials Soybean-casein Digest Broth In A Plastic Vial.

Pre-market Notification Details

Device IDK161810
510k NumberK161810
Device Name:BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth In A Plastic Vial
ClassificationSystem, Blood Culturing
Applicant BECTON DICKINSON 7 LOVETON CIRCLE, MC 694 Sparks,  MD  21152
ContactAshanti C. Brown
CorrespondentAshanti C. Brown
BECTON DICKINSON 7 LOVETON CIRCLE, MC 694 Sparks,  MD  21152
Product CodeMDB  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-01
Decision Date2017-02-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382904420278 K161810 000

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