CIPROFLOXACIN 5 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 Ciprofloxacin 5 Mcg Sensi-disc.

Pre-market Notification Details

Device IDK874425
510k NumberK874425
Device Name:CIPROFLOXACIN 5 MCG SENSI-DISC
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
ContactJ Arnsberger
CorrespondentJ Arnsberger
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-28
Decision Date1987-11-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382902316572 K874425 000
30382902316580 K874425 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.