BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS

System, Blood Culturing

BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS

The following data is part of a premarket notification filed by Becton Dickinson Diagnostic Instrument Systems with the FDA for Bactec Standard/10 Aerobic/f Culture Vials.

Pre-market Notification Details

Device IDK954921
510k NumberK954921
Device Name:BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS
ClassificationSystem, Blood Culturing
Applicant BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE Sparks,  MD  21152 -0999
ContactDennis R Mertz
CorrespondentDennis R Mertz
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE Sparks,  MD  21152 -0999
Product CodeMDB  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-26
Decision Date1996-02-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382904422609 K954921 000

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