BACTEC MGIT 960 SIRE KITS

Susceptibility Test Powders, Antimycobacterial

BECTON, DICKINSON & CO.

The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bactec Mgit 960 Sire Kits.

Pre-market Notification Details

Device IDK014123
510k NumberK014123
Device Name:BACTEC MGIT 960 SIRE KITS
ClassificationSusceptibility Test Powders, Antimycobacterial
Applicant BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks,  MD  21152 -0999
ContactJody J Hoffmann
CorrespondentJody J Hoffmann
BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks,  MD  21152 -0999
Product CodeMJA  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-17
Decision Date2002-04-19
Summary:summary

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