CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL 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 Cefotaxime/clavulanic, 30/10ug, Bbl Sensi-disc And Ceftazidime/clavulanic Acid, 30/10ug, Bbl Sensi-disc.

Pre-market Notification Details

Device IDK993577
510k NumberK993577
Device Name:CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIR. Sparks,  MD  21152 -0999
ContactMonica E Giguere
CorrespondentMonica E Giguere
BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIR. Sparks,  MD  21152 -0999
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-21
Decision Date1999-12-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382902317531 K993577 000
00382902317517 K993577 000
30382902317549 K993577 000
30382902317525 K993577 000

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