CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM

Kit, Identification, Enterobacteriaceae

BECTON DICKINSON MICROBIOLOGY SYSTEMS

The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Crystal Enteric/nonfermenter Id System.

Pre-market Notification Details

Device IDK926018
510k NumberK926018
Device Name:CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM
ClassificationKit, Identification, Enterobacteriaceae
Applicant BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville,  MD  21030 -0243
ContactRobert E James
CorrespondentRobert E James
BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville,  MD  21030 -0243
Product CodeJSS  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-30
Decision Date1993-03-11

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