CEFUROXIME 30 MCG 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 Cefuroxime 30 Mcg Sensi-disc.

Pre-market Notification Details

Device IDK832515
510k NumberK832515
Device Name:CEFUROXIME 30 MCG SENSI-DISC
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington,  DC  20006
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-28
Decision Date1983-10-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382902316214 K832515 000

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