TIGECYCLINE 15UG 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 Tigecycline 15ug Bbl Sensi-disc.

Pre-market Notification Details

Device IDK052853
510k NumberK052853
Device Name:TIGECYCLINE 15UG BBL SENSI-DISC
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant BECTON DICKINSON & CO. 7 LOVETON CIR. Sparks,  MD  21152
ContactDainelle Clark
CorrespondentDainelle Clark
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 Received2005-10-11
Decision Date2005-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382902320876 K052853 000
30382902322086 K052853 000

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