SPECTINOMYCIN 100 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 Spectinomycin 100 Mcg Sensi-disc.

Pre-market Notification Details

Device IDK891772
510k NumberK891772
Device Name:SPECTINOMYCIN 100 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 Received1989-03-24
Decision Date1989-08-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382902316375 K891772 000

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