TRIMETHROPRIM 5MCG. 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 Trimethroprim 5mcg. Sensi Disc..

Pre-market Notification Details

Device IDK801648
510k NumberK801648
Device Name:TRIMETHROPRIM 5MCG. 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 Received1980-07-18
Decision Date1980-08-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382902316016 K801648 000

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