BBL MGIT PRODUCTS

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 Bbl Mgit Products.

Pre-market Notification Details

Device IDK954932
510k NumberK954932
Device Name:BBL MGIT PRODUCTS
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 Received1995-10-27
Decision Date1996-08-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382902451168 K954932 000
30382902451144 K954932 000
30382902451137 K954932 000
30382902451113 K954932 000

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