CEFPROZIL 30MCG, 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 Cefprozil 30mcg, Sensi Disc.

Pre-market Notification Details

Device IDK920473
510k NumberK920473
Device Name:CEFPROZIL 30MCG, SENSI DISC
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 Cockeysville,  MD  21030 -0243
ContactRobert E James
CorrespondentRobert E James
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 Cockeysville,  MD  21030 -0243
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-28
Decision Date1992-03-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382902316849 K920473 000

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