BACTEC FUNGAL MEDIUM

Monitor, Microbial Growth

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 Fungal Medium.

Pre-market Notification Details

Device IDK954923
510k NumberK954923
Device Name:BACTEC FUNGAL MEDIUM
ClassificationMonitor, Microbial Growth
Applicant BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE Sparks,  MD  21152 -0999
ContactDavid R Mertz
CorrespondentDavid R Mertz
BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE Sparks,  MD  21152 -0999
Product CodeJTA  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-26
Decision Date1996-11-21
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.