BACTEC MYCO/F LYTIC CULTURE VIALS

System, Blood Culturing

BECTON DICKINSON MICROBIOLOGY SYSTEMS

The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Bactec Myco/f Lytic Culture Vials.

Pre-market Notification Details

Device IDK970512
510k NumberK970512
Device Name:BACTEC MYCO/F LYTIC CULTURE VIALS
ClassificationSystem, Blood Culturing
Applicant BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIR. Sparks,  MD  21152 -0999
ContactDennis R Mertz
CorrespondentDennis R Mertz
BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIR. Sparks,  MD  21152 -0999
Product CodeMDB  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-11
Decision Date1998-01-08
Summary:summary

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