DORIPENEM 10UG BBL SENSI-DISC

Susceptibility Test Discs, Antimicrobial

BECTON DICKINSON & CO.

The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Doripenem 10ug Bbl Sensi-disc.

Pre-market Notification Details

Device IDK080998
510k NumberK080998
Device Name:DORIPENEM 10UG BBL SENSI-DISC
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant BECTON DICKINSON & CO. 7 LOVETON CIR. Sparks,  MD  21152
ContactJanine Matlak
CorrespondentJanine Matlak
BECTON DICKINSON & CO. 7 LOVETON CIR. Sparks,  MD  21152
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-07
Decision Date2008-05-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382902322192 K080998 000

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