SYNERCID, 15 UG, BBL SENSI-DISC

Susceptibility Test Discs, Antimicrobial

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Synercid, 15 Ug, Bbl Sensi-disc.

Pre-market Notification Details

Device IDK993186
510k NumberK993186
Device Name:SYNERCID, 15 UG, BBL SENSI-DISC
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE Sparks,  MD  21152 -0999
ContactBradford M Spring
CorrespondentBradford M Spring
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE Sparks,  MD  21152 -0999
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-22
Decision Date1999-11-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382902317211 K993186 000

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