BACTEC MYCO/F-SPUTA 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-sputa Culture Vials.

Pre-market Notification Details

Device IDK972758
510k NumberK972758
Device Name:BACTEC MYCO/F-SPUTA CULTURE VIALS
ClassificationSystem, Blood Culturing
Applicant BECTON DICKINSON MICROBIOLOGY SYSTEMS 250 SCHILLING CIRCLE Cockeysville,  MD  21030 -0243
ContactColleen Rohrbeck
CorrespondentColleen Rohrbeck
BECTON DICKINSON MICROBIOLOGY SYSTEMS 250 SCHILLING CIRCLE Cockeysville,  MD  21030 -0243
Product CodeMDB  
CFR Regulation Number866.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-16
Decision Date1997-08-08
Summary:summary

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