PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISC

Susceptibility Test Discs, Antimicrobial

BECTON DICKINSON MICROBIOLOGY SYSTEMS

The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Piperacillin/tozobactam, 100/10 Mcg Sensi-disc.

Pre-market Notification Details

Device IDK940359
510k NumberK940359
Device Name:PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISC
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville,  MD  21030 -0243
ContactRobert E James
CorrespondentRobert E James
BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville,  MD  21030 -0243
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-04
Decision Date1994-03-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382902316916 K940359 000
30382902316924 K940359 000

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