CEFOTAXIME 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 Cefotaxime 30 Mcg. Sensi-disc..

Pre-market Notification Details

Device IDK810564
510k NumberK810564
Device Name:CEFOTAXIME 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 Received1981-03-03
Decision Date1981-03-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382902316060 K810564 000
30382902316078 K810564 000

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