CEFACLOR 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 Cefaclor Sensi-disc.

Pre-market Notification Details

Device IDK855135
510k NumberK855135
Device Name:CEFACLOR SENSI-DISC
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC MACK CENTRE DR. P.O.BOX 2224 Paramus,  NJ  07652
ContactRussell Arnsberger
CorrespondentRussell Arnsberger
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC MACK CENTRE DR. P.O.BOX 2224 Paramus,  NJ  07652
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-23
Decision Date1986-01-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382902316535 K855135 000

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